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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)
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change scores of Box and Block test (BBT)
Change scores of Upper-extremity Fugl-Myer Assessment (UEFMA)
Secondary outcome measures
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 moreTrial 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.
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Who is running the clinical trial?
Kessler FoundationLead Sponsor
173 Previous Clinical Trials
10,684 Total Patients Enrolled
Guang Yue, PhDStudy DirectorKessler Foundation
3 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a tattoo with metal-based ink on your head or neck.I am between 18 and 75 years old.You are scared of small, enclosed spaces.I have been diagnosed with a brain injury from a stroke or trauma.You cannot feel or move your hand.You have a history of drinking too much alcohol or using illegal drugs.I frequently suffer from migraines or chronic headaches.My health is stable and I don't plan to change my medications soon.You have had mental health conditions like schizophrenia, anxiety, depression, or PTSD in the past.My hand is very stiff and I can't move it well.I can travel to and participate in all required visits for the study.You have trouble seeing well enough to read instructions on a computer screen.You have metal implants in your body, like surgical clips or a pacemaker.I have or had tinnitus or severe hearing issues that were treated.I have difficulty moving my hands and fingers.I can sit and be active for 2 hours without heart, breathing, or pain issues.I or a family member have been diagnosed with epilepsy.I have severe skin damage on my scalp.I am on medication that could increase my risk of seizures.It has been over 6 months since my injury.
Research Study Groups:
This trial has the following groups:- Group 1: MusicGlove and Active HD-tDCS
- Group 2: MusicGlove and Sham HD-tDCS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are actively a part of this clinical experiment?
"Affirmative. The information found on clinicaltrials.gov denotes that this specific trial is looking for patients with the initial posting dated March 1st 2020 and subsequent updates concluded April 6th 2022. 24 individuals are needed to be enrolled from one location only."
Answered by AI
Are there open positions available for the current experiment?
"Confirmed. The clinicaltrials.gov database shows that this investigation is actively seeking participants, which was initially advertised on March 1st 2020 and has been updated as recently as April 6th 2022. At present, the study requires 24 patients from a single trial site."
Answered by AI
Does this experimental protocol accept participants aged seventy and above?
"This medical trial is interested in those who are between 18 and 75 years old."
Answered by AI
Who is qualified to take part in this experiment?
"Applicants who have upper limb complications and fall within the 18 to 75 year old age range are eligible for this research study. A total of 24 volunteers will be accepted overall."
Answered by AI
What objectives has this trial been designed to fulfill?
"This clinical trial will monitor the primary outcome of Change scores in Box and Block Test (BBT) through baseline, Post-training, and Followup measurements. Secondary measurements include Weighted Node degree (as an EEG functional connectivity measure), Dexterity and Speed Test (DAST), as well as Action Research Arm Test (ARAT). These assessments are designed to evaluate how motor networks respond to intervention, MusicGlove performance speed levels, and activity limitation respectively."
Answered by AI
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