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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
transcutaneous afferent patterned stimulation (TAPS)
Cala Clinic
Burlingame, California, United States
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).
Time frame: 4 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
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.
Time frame: 4 weeks
Bain and Findley Activities of Daily Living (BF-ADL)
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.
Time frame: 4 weeks
Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (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. Percentage of patients with ratings \< 4 (including very much improved, much improved and improved) were computed respectively for CGI-I and PGI-I.
Time frame: 4 weeks
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