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Behavioural Intervention

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)

Awards & highlights

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.

Treatment Details

Study Objectives

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

Primary study objectives

Change scores of Box and Block test (BBT)

Change scores of Upper-extremity Fugl-Myer Assessment (UEFMA)

Secondary study objectives

Change scores of Action Research Arm Test (ARAT)

Change scores of Dexterity and Speed Test (DAST)

Change scores of Nine Hole Peg Test (NHPT)

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: MusicGlove and Active HD-tDCSActive Control2 Interventions

During Active HD-tDCS, current up to 2mA will be delivered transiently for only 30 seconds and it will be turned ON for the remainder of 20 minutes.

Group II: MusicGlove and Sham HD-tDCSPlacebo Group1 Intervention

During Sham HD-tDCS, current up to 2mA will be delivered transiently for only 30 seconds to simulate the real-tDCS based skin sensation.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor

178 Previous Clinical Trials

10,964 Total Patients Enrolled

Guang Yue, PhDStudy DirectorKessler Foundation

3 Previous Clinical Trials

90 Total Patients Enrolled

Media Library

Targeted Noninvasive Brain Stimulation (T-NIBS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04057105 — N/A

Traumatic Brain Injury Research Study Groups: MusicGlove and Active HD-tDCS, MusicGlove and Sham HD-tDCS

Traumatic Brain Injury Clinical Trial 2023: Targeted Noninvasive Brain Stimulation (T-NIBS) Highlights & Side Effects. Trial Name: NCT04057105 — N/A

Targeted Noninvasive Brain Stimulation (T-NIBS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04057105 — N/A

~5 spots leftby Sep 2025

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