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Transcranial Magnetic Stimulation for Sensory Learning Studies
N/A
Recruiting
Led By Hannah J Block, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be between the ages of 18-45 years old and right-handed
Subjects must report being free of Covid symptoms in the week preceding testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study Summary
This trial is testing how well different techniques work to improve the accuracy of hand movements in people with damage to the sensorimotor areas of their brain.
Who is the study for?
This trial is for right-handed individuals aged 18-45, free of COVID symptoms and either fully vaccinated or with a recent negative test. Excluded are those with visual/hearing impairments, metal head implants (except titanium), severe hand/arm injuries, drug/alcohol use before testing, sleep deprivation, or certain medical conditions.Check my eligibility
What is being tested?
The study tests how brain stimulation using Theta burst transcranial magnetic stimulation affects sensorimotor learning. It aims to improve understanding of brain regions involved in maintaining accurate hand movements which could enhance rehabilitation for patients with brain lesions.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or temporary hearing changes due to the noise during the procedure. There's also a small risk of seizure but precautions are taken to minimize this.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old and right-handed.
Select...
I have not had any COVID-19 symptoms in the past week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Realignment
Secondary outcome measures
Motor cortex excitability (arms 1-3)
Tactile sensitivity (arms 1-3)
Target estimation variance
+2 moreTrial Design
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Ventral premotor cortex--Exp 2Experimental Treatment1 Intervention
Theta burst transcranial magnetic stimulation (cTBS) will be applied over Ventral premotor cortex.
Group II: Somatosensory cortex--Exp 1Experimental Treatment1 Intervention
Theta burst transcranial magnetic stimulation (cTBS) will be applied over primary somatosensory cortex.
Group III: Primary motor cortex--Exp 1Experimental Treatment1 Intervention
Theta burst transcranial magnetic stimulation (cTBS) will be applied over primary motor cortex.
Group IV: Cerebellar cortex--Exp 2Experimental Treatment1 Intervention
Theta burst transcranial magnetic stimulation (cTBS) will be applied over cerebellar cortex.
Group V: Anterior superior parietal lobule--Exp 2Experimental Treatment1 Intervention
Theta burst transcranial magnetic stimulation (cTBS) will be applied over Anterior superior parietal lobule.
Group VI: Vertex sham--Exp 1Placebo Group1 Intervention
Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.
Group VII: Vertex sham--Exp 2Placebo Group1 Intervention
Sham theta burst transcranial magnetic stimulation (cTBS) will be applied over the vertex.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,003 Total Patients Enrolled
3 Trials studying Basic Science
520 Patients Enrolled for Basic Science
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,064 Total Patients Enrolled
3 Trials studying Basic Science
520 Patients Enrolled for Basic Science
Hannah J Block, PhDPrincipal InvestigatorIndiana University, Bloomington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe headaches, glaucoma, heart, lung, high blood pressure, mental health issues, or learning/attention problems.I have had symptoms like those of Covid in the last week and am not fully vaccinated or haven't tested negative in the past 4 days.I am taking medication that could affect my brain's response to electrical stimulation.I am between 18 and 45 years old and right-handed.To make sure you don't have COVID-19, you need to either be fully vaccinated (wait 2+ weeks after your final vaccine dose) or have a negative COVID-19 test result within 4 days of the testing. Also, you should not have had any COVID-19 symptoms in the week before testing.I haven't had cancer in the last 5 years, except for skin cancer.I am between 18 and 45 years old and right-handed.I currently have an active cancer.I have not had any COVID-19 symptoms in the past week.I have conditions like vision or hearing issues, seizures, severe head trauma, fainting, or diabetes.I have a disorder that affects my lymph cells.I have had a serious hand or arm injury and haven't fully recovered.We will only test people who are right-handed because differences in brain function can affect the results of the test.
Research Study Groups:
This trial has the following groups:- Group 1: Vertex sham--Exp 1
- Group 2: Primary motor cortex--Exp 1
- Group 3: Somatosensory cortex--Exp 1
- Group 4: Anterior superior parietal lobule--Exp 2
- Group 5: Ventral premotor cortex--Exp 2
- Group 6: Cerebellar cortex--Exp 2
- Group 7: Vertex sham--Exp 2
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.
Are there vacancies to join this research study at present?
"According to the details available on clinicaltrials.gov, this medical trial is presently seeking participants. It was initially posted in late October 2021 and has since been updated at least once as of mid-October 2022."
Answered by AI
What criteria must potential participants satisfy to take part in this clinical trial?
"This trial is seeking a cohort of 150 individuals aged 18-45, who have no prior history with Covid. All potential subjects must be fully vaccinated or present a negative test within the last 4 days and report being free from infection symptoms in the week preceding testing. Further stipulations include right-handedness to circumvent any discrepancies between left and right arms as well as neurological effects caused by age differences outside of this range. Screening questions will be used to ensure that these requirements are met before enrolment."
Answered by AI
How many individuals is the trial recruiting at this time?
"Affirmative. The information on clinicaltrials.gov demonstrates that this study is currently enlisting participants; the trial was first featured October 26th 2021 and has been recently updated October 13th 2022. This research requires 150 patients from one site to partake in the experiment."
Answered by AI
Is the minimum age requirement for participants in this experiment eighteen years or older?
"According to the stated criteria, participants must be at least 18 years old and no older than 45."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
How old are they?
18 - 65
What site did they apply to?
Indiana University Bloomington
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- Indiana University Bloomington: < 24 hours
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