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Procedure

Brain and Spinal Cord Stimulation + Hand Training for Spinal Cord Injury

N/A

Waitlist Available

Led By Noam Y Harel, MD, PhD

Research Sponsored by Bronx VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand

Age between 18-85 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 10 months

Awards & highlights

Study Summary

This trial seeks to combine brain and spinal stimulation, alongside exercise, to improve hand function in people with chronic cervical SCI.

Who is the study for?

Adults aged 18-85 with stable cervical spinal cord injury (SCI) who can commit to many visits over 6-10 months, abstain from alcohol and heavy caffeine on experiment days, and have a certain level of hand muscle movement. Excluded are those with seizure risks, ventilator dependence, brain conditions like stroke or tumors, implanted stimulators or metal in the head, severe heart issues, skin lesions on upper body or pregnancy.Check my eligibility

What is being tested?

The trial is testing how synchronized brain and spinal cord stimulation combined with hand exercises can help people with chronic cervical SCI improve their hand function. It explores the best ways to apply this 'Spinal Cord Associative Plasticity' through numerous sessions tailored to each participant's response.See study design

What are the potential side effects?

Potential side effects may include discomfort at stimulation sites, headache due to stimulation intensity adjustments during sessions. There might also be a risk of seizures for susceptible individuals; however such participants are excluded from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move my fingers but not fully.

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I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Amplitude of motor evoked potential at the first dorsal interosseous muscle.

Secondary outcome measures

Pinch and grip strength

Trial Design

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment6 Interventions

Each participant will undergo varying conditions in separate phases to determine optimal: Pairing interval; Frequency; Number of bouts, Inter-bout spacing, and the order of SCAP when given in conjunction with task-oriented hand exercise.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise

2016

Completed Phase 1

~760

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bronx VA Medical CenterLead Sponsor

20 Previous Clinical Trials

1,276 Total Patients Enrolled

Bronx Veterans Medical Research Foundation, IncOTHER

9 Previous Clinical Trials

771 Total Patients Enrolled

New York State Department of HealthOTHER_GOV

34 Previous Clinical Trials

447,087 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over 35 eligible to sign up for this experiment?

"The upper-age limit for potential participants in this investigation is 85 years old, while the lower bound has been set to 18."

Answered by AI

Who meets the criteria to participate in this research trial?

"Candidates wishing to participate in this trial must have suffered from a spinal cord injury, and be between the ages of 18-85. This medical investigation is currently seeking up to 10 participants."

Answered by AI

Is this research experiment available to people at the present moment?

"As per clinicaltrials.gov, recruitment for this medical trial has been concluded since October 23rd 2023. The study was first posted on January 1st 2024; however, there are still 993 active trials in search of participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Finding the Best Combination of Brain and Spinal Cord Stimulation With Hand Training After Spinal Cord Injury

Noam Y. Harel 2024. "Finding the Best Combination of Brain and Spinal Cord Stimulation With Hand Training After Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06104735.

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