Noninvasive Brain Stimulation + Music-Assisted Therapy for Traumatic Brain Injury

N/A

Recruiting

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

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

Must have

Age between 18 and 75 years

Confirmed diagnosis of Acquired brain injury (individuals with stroke or Traumatic Brain Injury)

Must not have

Active history of migraine or chronic headache

Unable to move the hand because of muscle stiffness (scoring 3 or more on the Ashworth scale)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (before intervention), post-training (immediately after the end of 2-week intervention), followup (2 months after the end of intervention)

Summary

This trial will investigate the use of brain stimulation and music-assisted video game-based hand exercises to improve functional recovery in people with Acquired Brain Injury (ABI).

Who is the study for?

This trial is for adults aged 18-75 who have had a brain injury from stroke or trauma at least 6 months ago. They should be able to follow instructions, travel for multiple visits, and sit actively for 2 hours. Participants must have hand movement issues but can't join if they have severe eyesight problems, epilepsy history, skin scalp damage, extreme muscle stiffness in the hand, lost hand sensation, substance abuse history, certain mental illnesses or are pregnant.

What is being tested?

The study tests a combination of targeted noninvasive brain stimulation (HD-tDCS) and music-assisted video game exercises (MusicGlove) to improve hand functions in people with acquired brain injuries. It also examines changes in brain activity related to this intervention using EEG recordings before and after treatment.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the scalp, headache or fatigue during or after sessions with HD-tDCS. The MusicGlove exercise is generally safe but might cause tiredness due to repetitive movements.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I have been diagnosed with a brain injury from a stroke or trauma.

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I can sit and be active for 2 hours without heart, breathing, or pain issues.

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It has been over 6 months since my injury.

Exclusion Criteria

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

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I frequently suffer from migraines or chronic headaches.

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My hand is very stiff and I can't move it well.

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I have or had tinnitus or severe hearing issues that were treated.

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I or a family member have been diagnosed with epilepsy.

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I have severe skin damage on my scalp.

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I am on medication that could increase my risk of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (before intervention), post-training (immediately after the end of 2-week intervention), followup (2 months after the end of intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (before intervention), post-training (immediately after the end of 2-week intervention), followup (2 months after the end of intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (before intervention), post-training (immediately after the end of 2-week intervention), followup (2 months after the end of intervention) for reporting.