Clinical trial NCT05146648: Gondola Mechanism of Action
Official title: Mechanism of Action for Effects From Automated Mechanical Peripheral Stimulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Stroke
Cerebral Palsy
Parkinson's Disease
Keywords: ambulation
sensory stimulation
mobility
neurological disorder
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty adult individuals in the chronic phase of stroke, 20 people with cerebral palsy, 20 with Parkinson's Disease (intermediate stage) and 20 healthy volunteers will be randomized to receive sham or real AMPS intervention.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Soleus MVC
timeFrame: pre and post-AMPS (baseline and 2 minutes)
Secondary outcomes:
measure: Change in Tibialis anterior MVC
timeFrame: pre and post-AMPS (baseline and 2 minutes)
measure: Change in 10 meter walk test
timeFrame: pre and post-AMPS (baseline and 2 minutes)
Other outcomes:
Locations:
city: New York
country: United States
facility: Abilities Research Center
state: New York
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Gabriela Rozanski
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: David Putrino, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: