Gondola Mechanism of Action | NCT05146648

Studies
Gondola Mechanism of Action

NCT05146648

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Withdrawn

Last Update Posted

Jan 18, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Chronic Stroke
Cerebral Palsy
Parkinson's Disease

Interventions

Gondola AMPS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study withdrawn

Expanded Access Info

Start Date

Jan 12, 2023Actual

Primary Completion Date

Jan 12, 2023Actual

Completion Date

Jan 12, 2023Actual

First Submitted Date

Nov 23, 2021

First Submission Date that Met QC Criteria

Nov 23, 2021

First Posted Date

Dec 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2023

Last Update Posted Date

Jan 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Putrino, Director of Rehabilitation Innovation for the Mount Sinai Health System; Associate Professor, Rehabilitation Medicine, Icahn School of Medicine at Mount SinaiPrincipal Investigator

Lead Sponsor

Icahn School of Medicine at Mount SinaiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Real AMPS	Active Comparator	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.	Device: Gondola AMPS
Sham AMPS	Sham Comparator	AMPS therapy applied to two non-specific points on both feet.	Device: Gondola AMPS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gondola AMPS	Device	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriela Rozanski	MOUNT SINAI HOSPITAL	Study Director
David Putrino, PT, PhD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abilities Research Center		New York	New York	10029	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not applicable to study aims

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D010300	Parkinson Disease
D009422	Nervous System Diseases

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D020734	Parkinsonian Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

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.

Masking Info

Masking

Triple

Masking Description

A blinded evaluator will collect all the demographic (age, gender, time since injury, injury type), clinical and functional data of the participants. The investigator performing transcranial magnetic stimulation assessments will also be blinded.

Who Masked

ParticipantInvestigatorOutcomes Assessor