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Gondola Mechanism of Action

NCT05146648 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-01-18

No results posted yet for this study

Summary

This study will investigate the clinical, functional and neurophysiological effects of automated mechanical peripheral stimulation (AMPS) via the Gondola device administered to patients with chronic stroke, cerebral palsy and Parkinson's Disease. Results will be collected using standardized outcome measures and a transcranial magnetic stimulation assessment protocol including electrical stimulation and electromyographic recording.

Conditions

Interventions

DEVICE

Gondola AMPS

One treatment session lasts about two minutes and consists of the application of a mechanical pressure pulses on each of the points, one after the other, for a set duration (a few seconds), which is repeated several times in sequence.

Sponsors & Collaborators

Principal Investigators

  • Gabriela Rozanski · MOUNT SINAI HOSPITAL

  • David Putrino, PT, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2023-01-12
Completion
2023-01-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05146648 on ClinicalTrials.gov