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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cala Device
Sponsored by
Cala Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cala Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAPS delivered by Cala device

Arm Description

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

Outcomes

Primary Outcome Measures

Tremor Power
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).

Secondary Outcome Measures

Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
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.
Bain and Findley Activities of Daily Living (BF-ADL)
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.
Clinician and Patient Global Impressions of Improvement (CGI-I, PGI-I)
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.

Full Information

First Posted
August 3, 2021
Last Updated
August 12, 2021
Sponsor
Cala Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cala Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAPS delivered by Cala device
Arm Type
Experimental
Arm Description
Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.
Intervention Type
Device
Intervention Name(s)
Cala Device
Intervention Description
transcutaneous afferent patterned stimulation (TAPS)
Primary Outcome Measure Information:
Title
Tremor Power
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
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.
Time Frame
4 weeks
Title
Bain and Findley Activities of Daily Living (BF-ADL)
Description
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.
Time Frame
4 weeks
Title
Clinician and Patient Global Impressions of Improvement (CGI-I, PGI-I)
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cala Clinic
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States

12. IPD Sharing Statement

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

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