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Music Therapy + Brain Stimulation for Corticobasal Syndrome
N/A
Recruiting
Led By Alexander Pantelyat, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age range 18-89
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), day 8, day 10, day 15, day 17, day 22, day 24, and day 52
Awards & highlights
Study Summary
This trial will study the effects of musical patterns and brain stimulation on improving upper extremity function in patients with corticobasal syndrome.
Who is the study for?
This trial is for right-handed individuals aged 18-89 with corticobasal syndrome (CBS). It's not suitable for those with a history of seizures, skin conditions like psoriasis or eczema, psychological/neurological disorders, pregnancy, inability to follow study procedures, adverse reactions to brain stimulation techniques, migraines, metallic implants including pacemakers or past significant head injuries.Check my eligibility
What is being tested?
The study tests if music patterns (Patterned Sensory Enhancement) and non-invasive brain stimulation (transcranial Direct Current Stimulation) can improve arm function in CBS patients. Participants are divided into two groups; one receives only PSE while the other gets PSE plus tDCS over six sessions spanning three weeks.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 from tDCS. Since this involves non-invasive methods and musical intervention there are minimal risks compared to invasive treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 89 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1), day 8, day 10, day 15, day 17, day 22, day 24, and day 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), day 8, day 10, day 15, day 17, day 22, day 24, and day 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in TOLA score (command)
Change in TOLA score (imitation)
Change in TOLA score (limb)
+5 moreSecondary outcome measures
Change in score on anxiety level as assessed by the STAI
Change in score on arousal as assessed by the SAM
Change in score on depression level as assessed by the BDI-II
+4 moreOther outcome measures
Change in acceleration (m/s^2) of upper extremity performance
Change in power spectrum density of brainwave spectrum (micro-volts-squared per Hz)
Change in range of motion (degree) of upper extremity performance
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PSE+tDCSExperimental Treatment2 Interventions
Participants in this group will proceed with the same procedure as PSE only group, but tDCS modulation will be additionally provided.
Group II: PSE OnlyExperimental Treatment1 Intervention
Participants will exercise their hands, arms, shoulders, and torso with musical cues provided by neurologic music therapist. A simple gross/fine movements and emotional level will be assessed before and after each session. During the session, participants will be measured their brainwaves using electroencephalography (EEG) to understand their neurophysiological responses. Participant's motion will be also captured to acquire kinematic quantities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~2100
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,477 Total Patients Enrolled
Alexander Pantelyat, MDPrincipal InvestigatorDepartment of Neurology, Johns Hopkins School of Medicine
6 Previous Clinical Trials
156 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of migraines.You have had bad reactions to previous brain stimulation treatments.I have been diagnosed with a psychological or neurological disorder.You have any metal implants or devices in your body, like surgical clips or a pacemaker.I have a condition like psoriasis or eczema affecting my skin.You had a head injury that made you lose consciousness and needed more tests.I am between 18 and 89 years old.You are right-handed.I have had seizures in the past.I have CBS.
Research Study Groups:
This trial has the following groups:- Group 1: PSE Only
- Group 2: PSE+tDCS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are applicants of any age being considered for the experiment?
"This clinical trial mandates that all participants are between 18 and 89 years of age. There is a total of 376 trials open to minors and 993 for those above the retirement threshold."
Answered by AI
Is the research team currently looking for new participants?
"Contrary to what was previously anticipated, clinicaltrials.gov confirms that this particular trial is no longer actively seeking participants. The study first appeared on April 22nd 2022 and the most recent update happened on April 29th of the same year. However, there are currently 1,396 other studies recruiting patients at this time."
Answered by AI
To which demographic does this research initiative extend eligibility?
"Candidates who have the specified syndrome and are aged between 18-89 may be admitted to this trial. The team is hoping to recruit approximately 20 participants in total."
Answered by AI
What is the purpose of this experiment?
"This clinical trial will track Change in functional upper extremity performance score as assessed by the WMFT from Baseline (Day 1) to Day 8, Day 10, Day 15, Day 17, Day 22, day 24 and finally on completion of the study at Day 52. Secondary objectives involve monitoring changes in scores for levels of anxiety with STAI (State Trait Anxiety Inventory), valence through SAM (Self-Assessment Manikin), and quality of life using CBFS(Corticobasal Syndrome Functional Scale)."
Answered by AI
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