Gondola Mechanism of Action

Mount Sinai Health System

Status: Withdrawn

Conditions: Parkinson's Disease; Cerebral Palsy; Chronic Stroke

Treatments: Device: Gondola AMPS

Study type: Interventional

Funder types: Other

Identifiers

NCT05146648

STUDY-21-00837

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Real AMPS

Active Comparator group

Description:

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.

Treatment:

Device: Gondola AMPS

Sham AMPS

Sham Comparator group

Description:

AMPS therapy applied to two non-specific points on both feet.

Treatment:

Device: Gondola AMPS