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Procedure

SCAP plus task-oriented exercise for Amyotrophic Lateral Sclerosis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Amplitude of intrinsic hand muscle response to single-pulse transcranial magnetic stimulation (TMS)

Hand dexterity on the nine-hole peg test

Secondary outcome measures

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)

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,252 Total Patients Enrolled

3 Trials studying Amyotrophic Lateral Sclerosis

55 Patients Enrolled for Amyotrophic Lateral Sclerosis

Noam Y. Harel, MD PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center

2 Previous Clinical Trials

32 Total Patients Enrolled

1 Trials studying Amyotrophic Lateral Sclerosis

19 Patients Enrolled for Amyotrophic Lateral Sclerosis

Frequently Asked Questions

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

Who meets the qualifications for inclusion in this clinical trial?

"This clinical trial has strict requirements for eligibility, namely amyotrophic lateral sclerosis and an age range of 18 to 80. The research team is hoping to recruit up to 32 participants in total."

Answered by AI

Are there any current avenues for participants to join this experiment?

"As indicated on clinicaltrials.gov, this specific trial has stopped recruiting patients as of December 6th 2023. It was initially posted for recruitment in March 1st 2024 and unfortunately is not active at present; however, there are 528 other trials that currently require participants to enroll."

Answered by AI

Are there any age restrictions associated with this research study?

"The requirements for participation in this trial mandate that patients must be between the ages of 18-80. Alternatively, there are 39 investigations applicable to those aged under 18 and 399 studies dedicated to seniors over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Spinal Cord Associative Plasticity for ALS

2024. "Spinal Cord Associative Plasticity for ALS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06172621.

All > Lou Gehrigs Disease > Transcranial Magnetic Stimulation