Gondola Mechanism of Action

Parkinson's Disease Clinical Trial

Official title:

Mechanism of Action for Effects From Automated Mechanical Peripheral Stimulation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05146648
• Other study ID #: STUDY-21-00837
• Status: Withdrawn
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: January 12, 2023

Study information

• Verified date: June 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Chronic Stroke
• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Abilities Research Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Soleus MVC	maximum voluntary contraction of the soleus muscle (measured by EMG)	pre and post-AMPS (baseline and 2 minutes)
Secondary	Change in Tibialis anterior MVC	maximum voluntary contraction of tibialis anterior (measured by EMG)	pre and post-AMPS (baseline and 2 minutes)
Secondary	Change in 10 meter walk test	self-selected pace to determine gait speed	pre and post-AMPS (baseline and 2 minutes)