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

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
TAPS delivered by Cala device	Cala Device	Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening.

Primary Outcome Measures

Name	Time	Method
Tremor Power	4 weeks	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

Name	Time	Method
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	4 weeks	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.
Bain and Findley Activities of Daily Living (BF-ADL)	4 weeks	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.
Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I)	4 weeks	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.