NCT05146648

Gondola Mechanism of Action

Mechanism of Action for Effects From Automated Mechanical Peripheral Stimulation

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Stroke
• Cerebral Palsy
• Parkinson's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-12
• Primary completion: 2023-01-12
• Completion: 2023-01-12
• First posted: 2021-12-07
• Last updated: 2023-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study