## Protocol Section
### Identification Module
**NCT ID:** NCT05012579

**Brief Title:** Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor

**Official Title:** A Study of Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Action Tremor in Parkinson's Disease (PD)

#### Organization Study ID Info
**ID:** PD-02
#### Organization
**Class:** INDUSTRY
**Full Name:** Cala Health, Inc.
### Status Module
#### Completion Date
**Date:** 2021-03-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-13

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-03-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2024-02-13

**Type:** ACTUAL

**Results First Submit Date:** 2023-11-02

**Results First Submit QC Date:** 2024-01-22

#### Start Date
**Date:** 2020-11-11

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2021-08-19
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-03
**Study First Submit QC Date:** 2021-08-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Cala Health, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Demonstrate safety and efficacy of TAPS delivered by a Cala device as a treatment for action tremor in subjects with Parkinson's disease hand tremor

**Detailed Description:** 40 patients with PD with at least mild postural tremor were enrolled in a four-week, prospective, single-arm, open-label study of twice daily TAPS therapy. Due to the COVID-19 pandemic, TAPS devices were shipped to patients to run the study remotely. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.

### Conditions Module

**Conditions:**

- Parkinson Disease

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.

**Intervention Names:**

- Device: Cala Device

**Label:** TAPS delivered by Cala device

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TAPS delivered by Cala device

**Description:** transcutaneous afferent patterned stimulation (TAPS)

**Name:** Cala Device

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Pre-specified effectiveness endpoints included improvements in (1) objective postural tremor power (primary outcome; assessed using an accelerometer on the device under standard of care medication state at home).

**Measure:** Tremor Power

**Time Frame:** 4 weeks

#### Secondary Outcomes

**Description:** Improvement of clinician-ratings of Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) Part III \[Goetz, C.G. et al. Wiley Intersci. 2008\] (co-secondary; in medication-off state). Clinician rated patients' tremor pre and post therapy on a scale of 0-4. 0=Normal (no tremor), 4=Severe.

**Measure:** Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

**Time Frame:** 4 weeks

**Description:** Improvement of patient-ratings of the Bain and Findley Activities of Daily Living (BF-ADL) \[Bain PG, et al. Journal of Neurol, Neuros \& Psych 1993\] (co-secondary; in medication-off state). Patients' rated ability to perform specific activities pre and post therapy on a scale from 1-4. 1=Able to do the activity without difficulty, 4=Cannot do the activity by yourself.

**Measure:** Bain and Findley Activities of Daily Living (BF-ADL)

**Time Frame:** 4 weeks

**Description:** Clinician and Patient global impressions of improvement (CGI-I, PGI-I; exploratory) post therapy. This is a rated scale from 1-7, with 1=Very Much Improved to 7=Very Much Worse. Percentage of patients with ratings \< 4 (including very much improved, much improved and improved) were computed respectively for CGI-I and PGI-I.

**Measure:** Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I)

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Must be ≥22 years of age
* Competent and willing to provide written, informed consent to participate in the study
* Clinically significant postural tremor as defined by:

  * Dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the MDS-UPDRS postural tremor score
* Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry
* Willing to comply with study protocol requirements including:

  * Having the ability to do telemedicine or video calls for study visits
  * remaining on a stable dosage of Parkinson's medications, if applicable, during the duration of the study
  * no significant caffeine consumption within 8 hours of study visits

Exclusion Criteria:

* Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
* Suspected or diagnosed epilepsy or other seizure disorder
* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
* Peripheral neuropathy affecting the tested upper extremity
* Presence of any other neurodegenerative disease or dementia. These may include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
* Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
* Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
* Significant caffeine consumption within 8 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee).
* Subjects unable to communicate with the investigator and staff
* Any health condition that in the investigator's opinion should preclude participation in this study
* Pregnancy or anticipated pregnancy during the course of the study

**Minimum Age:** 22 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Burlingame

**Country:** United States

**Facility:** Cala Clinic

**State:** California

**Zip:** 94010

## Document Section

### Large Document Module

#### Large Docs

- Date: 2020-10-01

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 981852

- Type Abbrev: Prot

- Upload Date: 2023-11-02T11:41

- Date: 2021-03-25

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 733385

- Type Abbrev: SAP

- Upload Date: 2023-11-01T16:28

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000020820

- Term: Dyskinesias

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M16956

- Name: Tremor

- Relevance: HIGH

- As Found: Action Tremor

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

- ID: D000014202

- Term: Tremor

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2023-11-24

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** TAPS Delivered by Cala Device

**Deaths Num At Risk:** 40

**Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.

Cala Device: transcutaneous afferent patterned stimulation (TAPS)

**ID:** EG000

**Other Num Affected:** 8

**Other Num at Risk:** 40

**Serious Number At Risk:** 40

**Title:** TAPS Delivered by Cala Device

**Frequency Threshold:** 0

#### Other Events

**Term:** Unsteady gait

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** sore/lesion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** sore/lesion observed in 2 subjects, on the dominant wrist

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

**Source Vocabulary:** 

**Term:** significant and persistent skin irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** 

**Term:** persistent pain from stimulation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** pain felt in thumb of treatment hand

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

**Source Vocabulary:** 

**Term:** significant discomfort with stimulation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** twitching of ring finger

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** ring finger on treatment hand

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

**Source Vocabulary:** 

**Term:** anxiety/insomnia/worsening of tremor at night

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Time Frame:** 4 weeks

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 40

**Units:** Participants

### Group

**ID:** BG000

**Title:** TAPS Delivered by Cala Device

**Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.

Cala Device: transcutaneous afferent patterned stimulation (TAPS)

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.9

**Value:** 67.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 30

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** African American

#### Measurement

**Group ID:** BG000

**Value:** 33

**Category Title:** Caucasian

**Class Title:** Race

**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:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
**Population Description:** 40 enrolled subjects with PD
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** alex.kent@calahealth.com
**Organization:** Cala Health
**Phone:** 267-973-4180
**Title:** Alex Kent
## 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:** 54
- **Spread:** 
- **Upper Limit:** 79
- **Value:** 64
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.5
- **Upper Limit:** 
- **Value:** 0.6
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.5
- **Upper Limit:** 
- **Value:** 0.5
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 80
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 77
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Pre-specified effectiveness endpoints included improvements in (1) objective postural tremor power (primary outcome; assessed using an accelerometer on the device under standard of care medication state at home).
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 4 weeks
**Title:** Tremor Power
**Type:** PRIMARY
**Unit of Measure:** Percentage of tremor power reduction
##### Group
**Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.

Cala Device: transcutaneous afferent patterned stimulation (TAPS)
**ID:** OG000
**Title:** Single Arm - TAPS Delivered by Cala Device
#### Outcome Measure 2
**Description:** Improvement of clinician-ratings of Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) Part III \[Goetz, C.G. et al. Wiley Intersci. 2008\] (co-secondary; in medication-off state). Clinician rated patients' tremor pre and post therapy on a scale of 0-4. 0=Normal (no tremor), 4=Severe.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 4 weeks
**Title:** Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.

Cala Device: transcutaneous afferent patterned stimulation (TAPS)
**ID:** OG000
**Title:** Single Arm - TAPS Delivered by Cala Device
#### Outcome Measure 3
**Description:** Improvement of patient-ratings of the Bain and Findley Activities of Daily Living (BF-ADL) \[Bain PG, et al. Journal of Neurol, Neuros \& Psych 1993\] (co-secondary; in medication-off state). Patients' rated ability to perform specific activities pre and post therapy on a scale from 1-4. 1=Able to do the activity without difficulty, 4=Cannot do the activity by yourself.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 4 weeks
**Title:** Bain and Findley Activities of Daily Living (BF-ADL)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.

Cala Device: transcutaneous afferent patterned stimulation (TAPS)
**ID:** OG000
**Title:** Single Arm - TAPS Delivered by Cala Device
#### Outcome Measure 4
**Description:** Clinician and Patient global impressions of improvement (CGI-I, PGI-I; exploratory) post therapy. This is a rated scale from 1-7, with 1=Very Much Improved to 7=Very Much Worse. Percentage of patients with ratings \< 4 (including very much improved, much improved and improved) were computed respectively for CGI-I and PGI-I.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 4 weeks
**Title:** Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I)
**Type:** SECONDARY
**Unit of Measure:** percentage of patients with improvement
##### Group
**Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.

Cala Device: transcutaneous afferent patterned stimulation (TAPS)
**ID:** OG000
**Title:** Single Arm - TAPS Delivered by Cala Device
### Participant Flow Module
#### Group
**Description:** Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.

Cala Device: transcutaneous afferent patterned stimulation (TAPS)
**ID:** FG000
**Title:** TAPS Delivered by Cala Device
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 40
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 37
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
**Has Results:** True