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

NCT05012579 | Completed Results FDA Device

• 1 other identifier: PD-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  4 weeks

Secondary Outcomes (3)

• Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  4 weeks

• Bain and Findley Activities of Daily Living (BF-ADL)

  4 weeks

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

  4 weeks

Study Arms (1)

TAPS delivered by Cala device

EXPERIMENTAL

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

Device: Cala Device

Interventions

Cala Device DEVICE

transcutaneous afferent patterned stimulation (TAPS)

TAPS delivered by Cala device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cala Health, Inc.: lead

Study Sites (1)

Cala Clinic

Burlingame, California, 94010, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Alex Kent
• Organization: Cala Health

alex.kent@calahealth.com

267-973-4180

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 19, 2021
• Study Start: November 11, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: February 13, 2024
• Results First Posted: February 13, 2024

Record last verified: 2024-01

Locations

US (1)