Gondola Mechanism of Action

Not Applicable

Withdrawn

• Conditions: Chronic Stroke; Cerebral Palsy; Parkinson's Disease
• Interventions: Device: Gondola AMPS

• Registration Number: NCT05146648
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

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 Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-07
• Status Verified: 2022-06
• Study Start: 2023-01-12
• Primary Completion: 2023-01-12
• Study Completion: 2023-01-12
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real AMPS	Gondola 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.
Sham AMPS	Gondola AMPS	AMPS therapy applied to two non-specific points on both feet.

Primary Outcome Measures

Name	Time	Method
Change in Soleus MVC	pre and post-AMPS (baseline and 2 minutes)	maximum voluntary contraction of the soleus muscle (measured by EMG)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Abilities Research Center; 🇺🇸 New York, New York, United States