NCT03857867

Evaluation of Using Vibrotactile Coordinated Reset for Management of Parkinson's Disease

Terminated NA Results posted Last updated 21 December 2021

What this trial tests

NA trial testing Tactile Stimulation Glove in Parkinson Disease in 7 participants. Terminated before completion.

Timeline

1 February 2019

Primary endpoint
30 December 2020

30 December 2020

Quick facts

Lead sponsor	Peter Tass, MD, PhD
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	1 February 2019
Primary completion	30 December 2020
Estimated completion	30 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Tactile Stimulation Glove

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Peter Tass, MD, PhD

Who can join

18 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score Primary · Baseline, 3 months

The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms.

Baseline

Group	Value	95% CI
Tactile Stimulation Glove	38.33	± 5.93

3 months

Group	Value	95% CI
Tactile Stimulation Glove	32.33	± 7.80

Levodopa Equivalent Daily Dose Secondary · Baseline, 3 months

Levodopa equivalent daily dose (LEDD) was measured at baseline and after 3 months of vibrotactile coordinated reset therapy. LEDD is calculated as a sum of each Parkinson's medication.

Baseline LEDD

Group	Value	95% CI
Tactile Stimulation Glove	711.50	± 207.85

3 month LEDD

Group	Value	95% CI
Tactile Stimulation Glove	644.83	± 229.85

Electroencephalography (EEG) Sensorimotor Relative Power Activity Secondary · Baseline, 3 months

Measure Description: Baseline EEG was recorded. EEG source estimation was computed using Standardized low-resolution brain electromagnetic tomography analysis (sLORETA) and was restricted to the sensorimotor region. Power spectral density (PSD) was calculated for each frequency band (Delta: 2-4 Hz; Theta: 5-7 Hz; Alpha: 8-12 Hz; Low Beta: 13-16 Hz; Mid Beta: 17-20 Hz; High Beta: 21-30 Hz; Gamma: 31-50 Hz). Relative power (RP) was calculated by taking the sum of each frequency and dividing it by the total power (2-50 Hz) expressed as a percentage. High beta power was the frequency band of inter

Baseline high beta relative power

Group	Value	95% CI
Tactile Stimulation Glove	0.079	± 0.036

3 months high beta relative power

Group	Value	95% CI
Tactile Stimulation Glove	0.058	± 0.025

Sponsor's own description

This is a study to evaluate peripheral vibrotactile coordinated reset stimulation for Parkinson's disease seeks to explore the safety and efficacy of an experimental non-invasive method to aid in the symptoms of Parkinson's disease. The purpose of the study is to verify the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered to the fingertips of patients with Parkinson's disease.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.