## Protocol Section
### Identification Module
**NCT ID:** NCT01914679

**Acronym:** PERRFECT-UM

**Brief Title:** A Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - University of Michigan

**Official Title:** A Phase 2 Clinical Trial Evaluating Use of the NeuroPoint Medical Device as a Treatment for Fibromyalgia.

#### Organization Study ID Info
**ID:** NPT-201-UM
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2015-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-19

**Type:** ACTUAL

**Last Update Submit Date:** 2017-03-07

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2015-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-04-19

**Type:** ACTUAL

**Results First Submit Date:** 2017-01-04

**Results First Submit QC Date:** 2017-03-07

#### Start Date
**Date:** 2013-07

**Status Verified Date:** 2017-03

#### Study First Post Date
**Date:** 2013-08-02
**Type:** ESTIMATED
**Study First Submit Date:** 2013-07-23
**Study First Submit QC Date:** 2013-07-30
**Why Stopped:** Sponsor terminated the study
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Cerephex Corporation

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** Daniel Clauw, MD

**Investigator Title:** Professor of Anesthesiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the mechanisms of noninvasive cortical electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical Electrostimulation" RINCE)in the management of fibromyalgia. Patients who meet the 1990 American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 20 patients will receive a combination of active and inactive (sham) therapy treatments over a 16-week period followed by a 4 week post-treatment evaluation. Patients will also undergo three (3) functional brain imaging scans while participating in the study: the first prior to the commencement of treatment, another mid-treatment; and the third at the completion of the treatment period.

The study's primary outcome measure will be the change from baseline in self-reported 24-hour average pain intensity. The study's hypothesis is that there will be a change in pain intensity as well brain functioning. We do not expect there to be a statistically significant improvement in pain intensity due to the small sample but do expect to see statistically significant changes in cortical function as measured by EEG and fMRI

### Conditions Module

**Conditions:**

- Fibromyalgia

**Keywords:**

- Fibromyalgia

- Pain

- Brain

- Stimulation

- Device

- Treatment

### Design Module

#### Design Info

**Intervention Model:** SEQUENTIAL

**Intervention Model Description:** All participants went through a 4 week sham period, followed by a 12 week intervention with the device.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Participants did not know when the stimulation was occurring or not.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 17

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy followed by 12 weeks of RINCE therapy involving 24 total treatments

**Intervention Names:**

- Device: RINCE

**Label:** Sham followed by device

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Sham followed by device

**Description:** The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.

**Name:** RINCE

**Other Names:**

- RINCE therapy delivered by NeuroPoint Device

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** EEGs will be measured at the baseline, week 4, week 18 and week 21 visits.

**Measure:** Change in Network Connectivity as Measured by EEG

**Time Frame:** Baseline (week 1), week 6, week 18 and week 21

**Description:** The MASQ and MCS questionnaires will be administered at Baseline (week 1), week 6, week 10, week 14, week 18 and week 21.

**Measure:** Investigate Changes in Neurocognitive Functioning Using the MASQ and MCS Assessments.

**Time Frame:** Baseline and up to 21 weeks

**Description:** Subjects will undergo a neuroimaging scan at Baseline (week 1), week 6, and week 18. The scan will measure network connectivity during stimuli.

**Measure:** fMRI Measures of Network Connectivity

**Time Frame:** Baseline (week 1), week 6, and week 18

#### Primary Outcomes

**Description:** The units of measure represent self-reported average pain over the last 24 hours on a 0-100 pain rating scale where 0 is no pain and 100 is the worst pain imaginable.

.

**Measure:** Change in Patient 24-hour Recall Average Pain Intensity

**Time Frame:** Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient must provide written informed consent and privacy authorization prior to participation in the study. Patient must have the ability to read and/or follow written and oral instructions, abide by the study restrictions, and agree to return for the required assessments.
* Patient is female, 18-65 years of age (inclusive) at the time of consent.
* Patient must have a confirmed diagnosis of fibromyalgia meeting the ACR 1990 diagnostic criteria for fibromyalgia.
* Patients must have a 24-hour recall pain intensity score at both the screening and baseline visits between 40 and 90 inclusive on a 100 mm VAS scale.
* Female patient of childbearing potential must be willing to use an acceptable method of birth control for the duration of their study participation.
* Patients must be willing to refrain from all excluded therapies for the duration of the study.
* In the opinion of the Investigator, the patient is willing and able to comply with all protocol-specified requirements.
* Participants undergoing fMRI and 1H-MRS must be predominantly right handed (i.e. the subject writes with their right hand).

Exclusion Criteria:

The patient will not be eligible for enrollment if there is any history of, or in the opinion of the investigator, any of the following criteria are met:

* Patient has a current significant psychological or psychiatric disorder (e.g., severe, unstable or poorly controlled depression, severe anxiety or obsessive-compulsive disorder; history of suicide attempt within preceding 5 years or suicidal ideation within preceding 6 months; or any history of bipolar disorder, schizophrenia, schizoaffective or other psychotic disorder).
* Patient has a total Hospital and Anxiety Depression score of 11-21 for either anxiety or depression, or, based on the investigator's judgment, the patient is at risk of suicidal ideation or behavior.
* Patient is currently using prohibited medications or treatments (see Prohibited Concomitant Therapy section of protocol) including stimulants, anesthetic patches, CPAP and/or TENS therapy.
* Patient has an active diagnosis and is being treated for chronic infection or chronic condition such as lupus, rheumatoid arthritis, Parkinson's disease, multiple sclerosis, hepatitis, polio, seizures, or cancer (other than basal or squamous cell skin cancer).
* Patient has any other chronic pain condition other than fibromyalgia that, in the Investigator's opinion, would interfere with the assessment of fibromyalgia (e.g., rheumatoid arthritis, post herpetic neuralgia, pain associated with diabetic neuropathy, severe pain due to degenerative joint disease, etc.)
* Patient has history of seizure disorder, dementia or epilepsy anytime during his or her life except pediatric febrile seizures.
* Female patient who is pregnant, planning a pregnancy, or breastfeeding.
* Patient has any other disease or medical condition that, in the opinion of the investigator, would interfere with the evaluation of study device efficacy or safety, or would compromise the patient's ability to participate in or complete the study.
* Patient has a history of other cranial electrical stimulation device use, or electroconvulsive therapy.
* Patient has any metal implant, such as stents, aneurysm clips, shunts, pacemakers, defibrillators, neurostimulators or other contraindications with fMRI and 1H-MRS. Long-bone implants are not excluded.
* Any anticipated need for surgery that might confound results or interfere with patient's ability to comply with the protocol.
* Myocardial infarction during preceding 12 months, uncontrolled hypertension, active cardiac disease (American Heart Association Functional Class 2, 3 or 4 or Objective Class C or D), clinically significant cardiac rhythm or conduction abnormality, or anticipation of bypass or other cardiac surgery within the next 12 months.
* Current systemic infection (e.g., HIV, hepatitis).
* Patients receiving systemic corticosteroids (\> 5 mg prednisone or equivalent per day).
* Pending or current litigation or disability claim (including Workman's Compensation). Patients currently receiving disability benefits will require medical monitor approval on a case-by-case basis.
* Patient has history of alcohol and/or drug abuse.
* Patient has participated in any investigational study within 30 days prior to Screening visit or is currently participating in another clinical trial.
* Patient has received any prior experimental treatment or therapy that, in the opinion of the medical monitor, would compromise the patient's ability to participate in the study.
* Patient is a staff member or relative of a staff member at either the investigative site or the Cerephex Corporation.
* Body Mass Index (BMI) of greater than approximately 40 kg/m2.
* Claustrophobia or any other factor sufficiently significant that it is likely to prevent successful completion of fMRI and 1H-MRS procedures.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan

**State:** Michigan

**Zip:** 48106

#### Overall Officials

**Official 1:**

**Affiliation:** University of Michigan

**Name:** Daniel J Clauw, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M8486

- Name: Fibromyalgia

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M12161

- Name: Myofascial Pain Syndromes

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005356

- Term: Fibromyalgia

- ID: D000009209

- Term: Myofascial Pain Syndromes

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Sham and RINCE Treatment

**Description:** 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).

RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.

**ID:** EG000

**Other Num Affected:** 14

**Other Num at Risk:** 17

**Serious Number At Risk:** 17

**Title:** Sham and RINCE Treatment

**Frequency Threshold:** 5

#### Other Events

**Term:** Loss of Balance Resulting in Fall

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Leg cramp

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Cough/Congestion

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Night Sweats

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Chest Pain

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Stomach Flu (achiness, diarrhea, nausea, vomiting)

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Rash

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Tinnitis

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** 

**Term:** Skin Tenderness

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Yeast Infection

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Mental Fogginess

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Food Poisoning

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Sinus Infection

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Migraine

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Vomiting

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Itchy Ears/Throat

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Sore Throat

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Bad Dreams

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Stomach Pain/Constipation

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Ankle Pain

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Stomach Cramps

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Vertigo

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** 

**Term:** Myalgia

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Difficulty Focusing Vision

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** Shaking/Dizziness

**Organ System:** General disorders

**Source Vocabulary:** 

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 17

**Units:** Participants

### Group

**ID:** BG000

**Title:** Sham and RINCE Treatment

**Description:** 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).

RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 17

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 17

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** This mechanistic study wasn't powered to show statistically significant clinical improvement, even as originally planned. Sponsor terminated study early when they realized the devices were not delivering enough current to be of therapeutic benefit.
### Point of Contact
**Email:** dclauw@med.umich.edu
**Organization:** University of Michigan
**Phone:** 734-998-6901
**Title:** Daniel Clauw, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 15.68
- **Upper Limit:** 
- **Value:** 66.42
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 29.46
- **Upper Limit:** 
- **Value:** 49.83
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 24.34
- **Upper Limit:** 
- **Value:** 37.50
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 23.17
- **Upper Limit:** 
- **Value:** 32.18
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 24.52
- **Upper Limit:** 
- **Value:** 32.58
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 11
**Units:** Participants
#### Outcome Measure 2
#### Outcome Measure 3
#### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The units of measure represent self-reported average pain over the last 24 hours on a 0-100 pain rating scale where 0 is no pain and 100 is the worst pain imaginable.

.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One participant missing from analysis at Week 14/Mid-Treatment/Visit 27 due to missed visit.
**Reporting Status:** POSTED
**Time Frame:** Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)
**Title:** Change in Patient 24-hour Recall Average Pain Intensity
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).

RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.
**ID:** OG000
**Title:** Sham and RINCE Treatment
#### Outcome Measure 2
**Description:** EEGs will be measured at the baseline, week 4, week 18 and week 21 visits.
**Reporting Status:** NOT_POSTED
**Time Frame:** Baseline (week 1), week 6, week 18 and week 21
**Title:** Change in Network Connectivity as Measured by EEG
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 3
**Description:** The MASQ and MCS questionnaires will be administered at Baseline (week 1), week 6, week 10, week 14, week 18 and week 21.
**Reporting Status:** NOT_POSTED
**Time Frame:** Baseline and up to 21 weeks
**Title:** Investigate Changes in Neurocognitive Functioning Using the MASQ and MCS Assessments.
**Type:** OTHER_PRE_SPECIFIED
#### Outcome Measure 4
**Description:** Subjects will undergo a neuroimaging scan at Baseline (week 1), week 6, and week 18. The scan will measure network connectivity during stimuli.
**Reporting Status:** NOT_POSTED
**Time Frame:** Baseline (week 1), week 6, and week 18
**Title:** fMRI Measures of Network Connectivity
**Type:** OTHER_PRE_SPECIFIED
### Participant Flow Module
#### Group
**Description:** 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments), and 12 weeks of RINCE therapy (24 treatments).

RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.
**ID:** FG000
**Title:** Sham and RINCE Treatment
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** Sponsor terminated study
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
##### Milestone
**Type:** Began 12 Week Actual RINCE Treatment
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 17
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
**Has Results:** True