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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

Must not have

History of stroke, brain tumor, brain abscess, or multiple sclerosis

Significant coronary artery or cardiac conduction disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 10 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of stroke, brain tumor, brain abscess, or multiple sclerosis.

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I have a serious heart condition.

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I have had a recent heart attack and my heart's pumping ability is severely reduced.

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I've had sudden blood pressure increases with symptoms like headache or sweating in the past 6 months.

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I have had significant hearing issues.

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I have open skin wounds on my face, neck, shoulders, or arms.

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I am not taking medications like amphetamines or bupropion that can increase the risk of seizures.

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I rely on a ventilator or have a tracheostomy.

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I or my family have a history of seizures.

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I have a medical device implanted or a condition that doesn't allow brain or spine stimulation.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Pinch and grip strength

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~820

0 / 12Eligibility criteria met