Gondola Mechanism of Action

January 13, 2023 updated by: David Putrino, Icahn School of Medicine at Mount Sinai

Mechanism of Action for Effects From Automated Mechanical Peripheral Stimulation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The working hypothesis for this pre-post intervention study is that one session of AMPS will increase voluntary motor drive of the plantar-flexors (soleus) muscle. The primary outcome measure will be maximum voluntary contraction (MVC) of the soleus (measured by electromyography, EMG); the secondary outcome will be the MVC of the antagonist muscle, the tibialis anterior. Data will be collected before the first session compared to directly after. The same measures in sham-stimulated and healthy volunteers will serve as controls.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Abilities Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 to 80;
  • chronic stroke lesion >6 months after a cerebrovascular accident OR diagnosis of cerebral palsy OR Parkinson's Disease;
  • presence of some degree of motor function in the ankle flexor (Soleus motor power >1);
  • able to ambulate 10 meters without physical assistance.

Exclusion Criteria:

  • medically unstable condition;
  • presence of other concurrent neurological illness;
  • cognitive impairment (Montreal Cognitive Assessment score <23);
  • presence of any potential TMS risk factor: damaged skin at the site of stimulation;
  • presence of an electrically, magnetically or mechanically activated implant, an intracerebral vascular clip, or any other electrically sensitive support system;
  • family history of medication-resistant epilepsy;
  • past history of seizures or unexplained spells of loss of consciousness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Real AMPS
AMPS therapy consists of mechanical stimulations applied to two specific points on both feet: the tip of the big toe (hallux) and the first metatarsal joint.
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.
Other Names:
  • Automated Mechanical Peripheral Stimulation
Sham Comparator: Sham AMPS
AMPS therapy applied to two non-specific points on both feet.
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.
Other Names:
  • Automated Mechanical Peripheral Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Soleus MVC
Time Frame: pre and post-AMPS (baseline and 2 minutes)
maximum voluntary contraction of the soleus muscle (measured by EMG)
pre and post-AMPS (baseline and 2 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tibialis anterior MVC
Time Frame: pre and post-AMPS (baseline and 2 minutes)
maximum voluntary contraction of tibialis anterior (measured by EMG)
pre and post-AMPS (baseline and 2 minutes)
Change in 10 meter walk test
Time Frame: pre and post-AMPS (baseline and 2 minutes)
self-selected pace to determine gait speed
pre and post-AMPS (baseline and 2 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Study Director: Gabriela Rozanski, Mount Sinai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Actual)

January 12, 2023

Study Completion (Actual)

January 12, 2023

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-21-00837

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Not applicable to study aims

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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