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Procedure

SCAP and Hand Exercises for ALS

N/A

Recruiting

Led By Noam Y. Harel, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Diagnosis of ALS by Gold Coast Criteria (Shefner et al. 2020) or "definite" or "probable" ALS by revised El Escorial Criteria (Brooks et al. 2000)

Incomplete weakness: Score of 1, 2, 3, or 4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand

Must not have

History of severe head trauma (evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging)

History of significant tinnitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if pairing brain & spinal cord stimulation with hand exercises can improve hand strength in Veterans with ALS.

Who is the study for?

This trial is for Veterans with ALS, a motor neuron disease. It's more inclusive than most studies, giving many Veterans the chance to join in research for this service-connected condition. Specific eligibility details are not provided but generally include those affected by ALS.

What is being tested?

The study tests whether customized brain-spinal stimulation combined with hand exercises can improve hand strength and function in ALS patients compared to either treatment alone. Participants will undergo two-week programs of these interventions.

What are the potential side effects?

Potential side effects are not detailed, but may include discomfort or other reactions related to electrical and magnetic stimulation or exercise regimens specific to individuals with neurodegenerative conditions like ALS.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with ALS according to specific medical criteria.

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I have some weakness in my hand movements.

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My muscle response to nerve stimulation tests is strong and within normal limits.

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My muscle response to a nerve stimulation test is strong and within normal limits.

Exclusion Criteria

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

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I have had a severe head injury with brain damage or skull fracture.

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I have a history of severe ringing in my ears.

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I am not taking medications like amphetamines that increase my risk of seizures.

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I have severe heart disease or my heart's pumping ability is significantly reduced.

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I have open skin wounds where the device would be placed.

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I have a history of seizures.

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I rely on a ventilator to breathe or have an open tracheostomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 6 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 intrinsic hand muscle response to single-pulse transcranial magnetic stimulation (TMS)

Hand dexterity on the nine-hole peg test

Secondary study objectives

Volitional strength assessed by isometric dynamometry (grip configuration)

Volitional strength assessed by isometric dynamometry (key-pinch configuration)

Volitional strength assessed by isometric dynamometry (tip-to-tip configuration)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SCAP plus task-oriented exerciseExperimental Treatment2 Interventions

After a run-in phase of 2-4 months to determine individualized stimulation parameters, participants will be randomized into a comparator group of two weeks (6 sessions) of SCAP intervention plus upper extremity task-oriented exercise.

Group II: SCAP aloneActive Control1 Intervention

After a run-in phase of 2-4 months to determine individualized stimulation parameters, participants will be randomized into a comparator group of two weeks (6 sessions) of SCAP intervention alone.

0 / 11Eligibility criteria met