Trial Outcomes & Findings for Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor (NCT NCT05012579)

NCT ID: NCT05012579

Last Updated: 2024-02-13

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2024-02-13

Participant Flow

Participant milestones

Measure	TAPS Delivered by Cala Device Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS)
Overall Study STARTED	40
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	TAPS Delivered by Cala Device n=40 Participants Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS)
Age, Continuous	67.1 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Single Arm - TAPS Delivered by Cala Device n=36 Participants Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS)
Tremor Power	64 Percentage of tremor power reduction Interval 54.0 to 79.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Arm - TAPS Delivered by Cala Device n=36 Participants Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS)
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	0.6 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Arm - TAPS Delivered by Cala Device n=36 Participants Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS)
Bain and Findley Activities of Daily Living (BF-ADL)	0.5 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Arm - TAPS Delivered by Cala Device n=36 Participants Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS)
Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I) PGI-I	80 percentage of patients with improvement
Percentage of Patients With Clinician and Patient Global Impressions of Improvement Rated < 4 (CGI-I, PGI-I) CGI-I	77 percentage of patients with improvement

Adverse Events

TAPS Delivered by Cala Device

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TAPS Delivered by Cala Device n=40 participants at risk Two 40-minute TAPS sessions daily for 28 days, recommended as once in the morning and once in the evening. Cala Device: transcutaneous afferent patterned stimulation (TAPS)
General disorders Unsteady gait	2.5% 1/40 • 4 weeks
Skin and subcutaneous tissue disorders sore/lesion	5.0% 2/40 • 4 weeks
Skin and subcutaneous tissue disorders significant and persistent skin irritation	2.5% 1/40 • 4 weeks
Musculoskeletal and connective tissue disorders persistent pain from stimulation	2.5% 1/40 • 4 weeks
General disorders significant discomfort with stimulation	2.5% 1/40 • 4 weeks
Musculoskeletal and connective tissue disorders twitching of ring finger	2.5% 1/40 • 4 weeks
General disorders anxiety/insomnia/worsening of tremor at night	2.5% 1/40 • 4 weeks

Additional Information

Alex Kent

Cala Health

Phone: 267-973-4180

Email: alex.kent@calahealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place