## Protocol Section
### Identification Module
**NCT ID:** NCT01795079

**Brief Title:** Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury

**Official Title:** Boston-Harvard Burn Injury Model System: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury

#### Organization Study ID Info
**ID:** 2012-p-001996
#### Organization
**Class:** OTHER
**Full Name:** Spaulding Rehabilitation Hospital
### Status Module
#### Completion Date
**Date:** 2020-04-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-17

**Type:** ACTUAL

**Last Update Submit Date:** 2021-02-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-03-17

**Type:** ACTUAL

**Results First Submit Date:** 2020-12-02

**Results First Submit QC Date:** 2021-02-23

#### Start Date
**Date:** 2013-01

**Status Verified Date:** 2021-02

#### Study First Post Date
**Date:** 2013-02-20
**Type:** ESTIMATED
**Study First Submit Date:** 2013-02-15
**Study First Submit QC Date:** 2013-02-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** FED

**Name:** U.S. Department of Education

#### Lead Sponsor

**Class:** OTHER

**Name:** Spaulding Rehabilitation Hospital

#### Responsible Party

**Investigator Affiliation:** Spaulding Rehabilitation Hospital

**Investigator Full Name:** Felipe Fregni

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.

If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

### Conditions Module

**Conditions:**

- Burn Injury

- Chronic Pain

- Pruritus

- Itching

**Keywords:**

- transcranial stimulation

- direct current

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects will undergo 20 minutes active tDCS.

**Intervention Names:**

- Device: Transcranial direct current stimulation (tDCS)

**Label:** Active tDCS

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects will undergo 20 minutes of sham stimulation.

**Intervention Names:**

- Device: Transcranial direct current stimulation (tDCS)

**Label:** Sham tDCS

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active tDCS

- Sham tDCS

**Description:** Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

**Name:** Transcranial direct current stimulation (tDCS)

**Other Names:**

- 1x1 low-intensity direct current stimulator

- Soterix Medical

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** Determine whether anodal transcranial direct current stimulation is effective in increasing quality of life in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Veterans RAND 36 Item Health Survey (VR-36). There are eight domains total including: bodily pain, role limitations due to physical problems, physical functioning, general health perception, vitality, social functioning, and role limitations due to mental health issues. Scores for each domain are from 0-100 with a higher score defining a more favorable health outcome.

**Measure:** Change in Quality of Life Scale

**Time Frame:** 2 weeks

**Description:** Determine whether anodal transcranial direct current stimulation is effective in increasing community integration functional outcomes in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Community Integration Questionnaire (CIQ). Total CIQ scores were used as the outcome measure. Contains 15 itms assessing community integrations across three domains (Home integration, social integration, productive activity) . The total score can range from 0 to 29 points (0 - minimal integration to 29 -maximal integration). A positive change indicates an improvement in integration.

**Measure:** Change in Community Integration Scale

**Time Frame:** 2 weeks

#### Primary Outcomes

**Description:** Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with neuropathic pain due to burn injury, as measured by changes in the Brief Pain Inventory (BPI). Brief Pain Inventory (BPI) consist consists of a 9 part questionnaire. The questions include the severity of pain levels (worst, least, average, \& current), the impact of pain on daily functioning in different areas (mood, walking, relationships, sleep, normal work, \& general activity), current treatments and perceived effectiveness of current treatments. The VAS Pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring patients' worst pain and least pain, on average and at present time.

**Measure:** Change in Pain Scale

**Time Frame:** 2 weeks

**Description:** Determine whether anodal transcranial direct current stimulation is effective in reducing itch severity/activity in subjects with neuropathic itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS) .This is a 0 to 10 scale, where 0 indicates no intensity and a 10 indicates unbearable intensity of itching.

**Measure:** Change in Itch Severity/Activity Scale

**Time Frame:** 2 weeks

#### Secondary Outcomes

**Description:** Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of depression in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) contains 21 questions, each answer being scored on a scale value of 0 to 3 (total from 0-63). Higher total scores indicate more severe depressive symptoms.

**Measure:** Change in Depression Scale

**Time Frame:** 2 weeks

**Description:** Determine whether anodal transcranial direct current stimulation is effective in decreasing post-traumatic stress symptoms in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Impact of Event Scale Revised (IES-R).This 22-item scale is designed to measure severity of PTS symptoms associated with a traumatic event. Subjects rate their level of distress associated with the event on a 0-4 scale (0 means not at all distressed, 4 means extremely distressed). The IES-R yields a total score (ranging from 0 to 88) where higher scores represent higher stress

**Measure:** Change in Post-Traumatic Stress Symptoms Scale

**Time Frame:** 2 weeks

**Description:** Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of anxiety in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS).This is a self-evaluation scale that ranges from 0 to 10, where 0 means no anxiety and 10 means the worst anxiety ever.

**Measure:** Change in Anxiety Scale

**Time Frame:** 2 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Providing informed consent to participate in the study
* Age 18 or older
* Burn injury with pain and/or itch that is moderate to severe
* Burn injury occurring at least 3 weeks prior to enrollment

Exclusion Criteria:

* Subjects with burns in scalp in the area of electrode placement
* Psychiatric disorders that have led to hospitalization within the past 6 months or signs of suicidality
* Learning disorders that may prevent patient's ability to complete assessments
* Unstable conditions preventing travel to study site
* Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment: carbamazepine, oxcarbazepine, phenytoin
* Contraindications to tDCS including implanted metal plates in the head or implanted brain medical devices
* Pregnancy at time of enrollment
* History of other neurological conditions associated with structural anatomical changes (i.e. stroke, brain injury, Parkinson's)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boston

**Country:** United States

**Facility:** Spaulding Rehabilitation Hospital

**State:** Massachusetts

**Zip:** 02129

#### Overall Officials

**Official 1:**

**Affiliation:** Spaulding Rehabilitation Hospital

**Name:** Felipe Fregni, MD PhD MPH

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Boston-Harvard Burn Injury Model System Website

**URL:** http://www.bh-bims.org

## Document Section

### Large Document Module

#### Large Docs

- Date: 2016-03-21

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1036371

- Type Abbrev: Prot_SAP

- Upload Date: 2021-02-02T17:04

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000012871

- Term: Skin Diseases

- ID: D000012877

- Term: Skin Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M5326

- Name: Burns

- Relevance: HIGH

- As Found: Burn Injury

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14396

- Name: Pruritus

- Relevance: HIGH

- As Found: Pruritus

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15680

- Name: Skin Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011537

- Term: Pruritus

- ID: D000059350

- Term: Chronic Pain

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000002056

- Term: Burns

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Active tDCS

**Deaths Num At Risk:** 16

**Description:** Subjects will undergo 20 minutes active tDCS.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

**ID:** EG000

**Other Num Affected:** 2

**Other Num at Risk:** 16

**Serious Number At Risk:** 16

**Title:** Active tDCS

**Group ID:** EG001

**Title:** Sham tDCS

**Deaths Num At Risk:** 15

**Description:** Subjects will undergo 20 minutes of sham stimulation.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

**ID:** EG001

**Other Num Affected:** 5

**Other Num at Risk:** 15

**Serious Number At Risk:** 15

**Title:** Sham tDCS

**Frequency Threshold:** 0

#### Other Events

**Term:** Hedache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Time Frame:** Period of stimulation (3 weeks)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 16

**Group ID:** BG001

**Value:** 15

**Group ID:** BG002

**Value:** 31

**Units:** Participants

### Group

**ID:** BG000

**Title:** Active tDCS

**Description:** Subjects will undergo 20 minutes active tDCS.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

### Group

**ID:** BG001

**Title:** Sham tDCS

**Description:** Subjects will undergo 20 minutes of sham stimulation.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14

**Value:** 49

#### Measurement

**Group ID:** BG001

**Spread:** 14

**Value:** 48

#### Measurement

**Group ID:** BG002

**Spread:** 14

**Value:** 48.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 16

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 15

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 29

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** fregni.felipe@mhg.harvard.edu
**Organization:** Spaulding Rehabilitation Hospital
**Phone:** 6179526158
**Title:** Felipe Fregni
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.94
- **Upper Limit:** 
- **Value:** 4.45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.45
- **Upper Limit:** 
- **Value:** 4.19
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.91
- **Upper Limit:** 
- **Value:** 3.65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.76
- **Upper Limit:** 
- **Value:** 1.83
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.1
- **Upper Limit:** 
- **Value:** 9.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.8
- **Upper Limit:** 
- **Value:** 9.2
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.6
- **Upper Limit:** 
- **Value:** 10.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 16.5
- **Upper Limit:** 
- **Value:** 36.3
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.62
- **Upper Limit:** 
- **Value:** 3.25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.37
- **Upper Limit:** 
- **Value:** 2.92
**Title:** 
#### Outcome Measure 6
#### Outcome Measure 7
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with neuropathic pain due to burn injury, as measured by changes in the Brief Pain Inventory (BPI). Brief Pain Inventory (BPI) consist consists of a 9 part questionnaire. The questions include the severity of pain levels (worst, least, average, \& current), the impact of pain on daily functioning in different areas (mood, walking, relationships, sleep, normal work, \& general activity), current treatments and perceived effectiveness of current treatments. The VAS Pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring patients' worst pain and least pain, on average and at present time.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** blinded assessment of scores at the primary endpoint (2 weeks)
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** Change in Pain Scale
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Subjects will undergo 20 minutes active tDCS.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG000
**Title:** Active tDCS
##### Group
**Description:** Subjects will undergo 20 minutes of sham stimulation.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG001
**Title:** Sham tDCS
#### Outcome Measure 2
**Description:** Determine whether anodal transcranial direct current stimulation is effective in reducing itch severity/activity in subjects with neuropathic itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS) .This is a 0 to 10 scale, where 0 indicates no intensity and a 10 indicates unbearable intensity of itching.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** blinded assessment at primary endpoint (2 weeks)
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** Change in Itch Severity/Activity Scale
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Subjects will undergo 20 minutes active tDCS.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG000
**Title:** Active tDCS
##### Group
**Description:** Subjects will undergo 20 minutes of sham stimulation.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG001
**Title:** Sham tDCS
#### Outcome Measure 3
**Description:** Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of depression in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) contains 21 questions, each answer being scored on a scale value of 0 to 3 (total from 0-63). Higher total scores indicate more severe depressive symptoms.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** blinded assessment of scores at the primary endpoint (2 weeks)
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** Change in Depression Scale
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Subjects will undergo 20 minutes active tDCS.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG000
**Title:** Active tDCS
##### Group
**Description:** Subjects will undergo 20 minutes of sham stimulation.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG001
**Title:** Sham tDCS
#### Outcome Measure 4
**Description:** Determine whether anodal transcranial direct current stimulation is effective in decreasing post-traumatic stress symptoms in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Impact of Event Scale Revised (IES-R).This 22-item scale is designed to measure severity of PTS symptoms associated with a traumatic event. Subjects rate their level of distress associated with the event on a 0-4 scale (0 means not at all distressed, 4 means extremely distressed). The IES-R yields a total score (ranging from 0 to 88) where higher scores represent higher stress
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** blinded assessment of scores at the primary endpoint(2 weeks)
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** Change in Post-Traumatic Stress Symptoms Scale
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Subjects will undergo 20 minutes active tDCS.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG000
**Title:** Active tDCS
##### Group
**Description:** Subjects will undergo 20 minutes of sham stimulation.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG001
**Title:** Sham tDCS
#### Outcome Measure 5
**Description:** Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of anxiety in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS).This is a self-evaluation scale that ranges from 0 to 10, where 0 means no anxiety and 10 means the worst anxiety ever.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** blinded assessment at the primary endpoint (2 weeks)
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** Change in Anxiety Scale
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Subjects will undergo 20 minutes active tDCS.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG000
**Title:** Active tDCS
##### Group
**Description:** Subjects will undergo 20 minutes of sham stimulation.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** OG001
**Title:** Sham tDCS
#### Outcome Measure 6
**Description:** Determine whether anodal transcranial direct current stimulation is effective in increasing quality of life in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Veterans RAND 36 Item Health Survey (VR-36). There are eight domains total including: bodily pain, role limitations due to physical problems, physical functioning, general health perception, vitality, social functioning, and role limitations due to mental health issues. Scores for each domain are from 0-100 with a higher score defining a more favorable health outcome.
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 weeks
**Title:** Change in Quality of Life Scale
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 7
**Description:** Determine whether anodal transcranial direct current stimulation is effective in increasing community integration functional outcomes in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Community Integration Questionnaire (CIQ). Total CIQ scores were used as the outcome measure. Contains 15 itms assessing community integrations across three domains (Home integration, social integration, productive activity) . The total score can range from 0 to 29 points (0 - minimal integration to 29 -maximal integration). A positive change indicates an improvement in integration.
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 weeks
**Title:** Change in Community Integration Scale
**Type:** OTHER_PRE_SPECIFIED
### Participant Flow Module
#### Group
**Description:** Subjects will undergo 20 minutes active tDCS.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** FG000
**Title:** Active tDCS
#### Group
**Description:** Subjects will undergo 20 minutes of sham stimulation.

Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
**ID:** FG001
**Title:** Sham tDCS
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 15
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Pre-Assignment Details:** Please note that 34 subjects consented to participated but 3 were screened out (after consent, there are additional tests to determine eligibility) and/or they dropped out before randomization (therefore, only 31 subjects were randomized).
**Has Results:** True