NCT04683471

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

December 15, 2020

Last Update Submit

April 11, 2022

Conditions

Spinal Cord Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Neuromodulation

EXPERIMENTAL

Neuromodulation

Device: Stimulator

Sham

SHAM COMPARATOR

Sham

Device: Sham

Interventions

StimulatorDEVICE

Neuromodulation

Neuromodulation
ShamDEVICE

Sham

Sham

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic chronic spinal cord injury

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Spinal Cord Diseases

Interventions

Tissue Therapy, Historical

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

OrganotherapyBiological TherapyTherapeuticsComplementary Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 24, 2020

Study Start

November 30, 2020

Primary Completion

December 22, 2021

Study Completion

March 22, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

US(3)