Pilot Trial of a System for Motor Function Recovery | NCT04683471

Studies
Pilot Trial of a System for Motor Function Recovery

NCT04683471

Sponsor

Niche Biomedical, Inc. dba ANEUVO

Status

Completed

Last Update Posted

Apr 13, 2022Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Spinal Cord Diseases

Interventions

Stimulator
Sham

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2020Actual

Primary Completion Date

Dec 22, 2021Actual

Completion Date

Mar 22, 2022Actual

First Submitted Date

Dec 15, 2020

First Submission Date that Met QC Criteria

Dec 21, 2020

First Posted Date

Dec 24, 2020Actual

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

Apr 11, 2022

Last Update Posted Date

Apr 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multi-center, prospective, blinded, pilot feasibility study to evaluate improvement in sensory and motor function with sham.

Detailed Description

Not provided

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neuromodulation	Experimental	Neuromodulation	Device: Stimulator
Sham	Sham Comparator	Sham	Device: Sham

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stimulator	Device	Neuromodulation	Neuromodulation
Sham

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) for the upper limbs Scoring: Strength scored 0 - 50 for each arm Sensibility scored 0 - 24 for each arm Prehension scored 0 - 42 for each arm Higher scores are a better outcome	Biweekly through study completion up to 18 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Traumatic chronic spinal cord injury

Exclusion Criteria:

Active implanted medical device
Internal metallic objects of unknown or foreign origin
Implanted anti-spasticity pumps, Botox injections in prior 3 months or other current anti-spasticity regimen
BMI > 40.0
Acute medical conditions under active treatment that would contraindicate standard rehabilitation including open wounds
Pregnancy or planned pregnancy
Unhealed bone fractures, peripheral neuropathies or painful musculoskeletal dysfunction
Cardiopulmonary disease or ventilator dependency
Uncontrolled epilepsy or seizures
Clinically significant depression, psychiatric disorders or ongoing substance abuse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shirley Ryan AbilityLab		Chicago	Illinois	60611	United States
Kennedy Krieger Institute

Condition Browse Module

MeSH Terms

ID	Term
D013118	Spinal Cord Diseases

Ancestor Terms

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014023	Tissue Therapy, Historical

Ancestor Terms

ID	Term
D009945	Organotherapy
D001691	Biological Therapy
D013812	Therapeutics
D000529	Complementary Therapies

Browse Leaves

Not provided

Browse Branches

Not provided