N/A
N=40
Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT05012579 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Tremor Power — 64 Percentage of tremor power reduction
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cala Device (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Cala Health, Inc.
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tremor Power |
64 | — |
| SECONDARY Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) |
0.6 | — |
| SECONDARY Bain and Findley Activities of Daily Living (BF-ADL) |
0.5 | — |
| SECONDARY Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I) |
80; 77 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT05012579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.