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

Completed · Not applicable

Conditions studied: Parkinson Disease

In brief

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

Key facts

Study ID

NCT05012579

Run by

Cala Health, Inc.

People needed

40

Starts

2020-11-11

Expected to finish

2021-03-12

Last updated by the study team

2024-02-13

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Cala Clinic — Burlingame, California, United States

Full record on ClinicalTrials.gov

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