- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07588113
rTMS Induced Reduction in M1 Excitability
The Effects of rTMS Induced Reduction in M1 Excitability on Early-online Learning and Retention in Dexterous Video-game Task
Study Overview
Status
Intervention / Treatment
Detailed Description
Research employing rTMS-induced reductions in excitability showed that M1 had a large role in consolidation after practice, but was not responsible for the improvements that occur during practice. Though this study used a simple finger tapping task, additional studies have shown the role of M1 in task consolidation with ballistic movements and dynamic force-field learning tasks, while using rTMS to reduce cortical excitability. The main issue with previous studies is that they have been limited to a single digit, single joint, or non-transferrable laboratory tasks. This limits the application of these studies to real world scenarios, and shows the need for further research into this interaction. Therefore, we intend to examine the effect of an rTMS-induced reduction in M1 excitability, on the learning of a dynamic, two-handed video game task (Guitar Hero). This is important because it will help explain the role of M1 in learning complex, bimanual tasks. Our study will also directly address how M1 contributes to the fast and slow consolidation of dynamic, coordinated actions that more closely resemble real-world activities (video games). Ultimately, this knowledge is crucial to the development of targeted non-invasive brain stimulation protocols that could aid in the rehabilitation of patients with motor dysfunction, in which relearning complex coordinated motor tasks is a primary goal.
Objective(s)
- Primary Objective Our primary objective is to determine if short term inhibition of M1 with 1Hz rTMS (rTMS induced reductions in excitability) blocks the early online learning (fast and slow consolidation) that occurs when first playing a video game
- Secondary Objective Our secondary objective is to compare the amount of rTMS-induced reductions in excitability, measured with single pulse TMS motor-evoked potential cortical excitability, with the amount of fast and slow consolidation observed in playing the video game.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zachary A Riley
- Phone Number: 317-274-1487
- Email: zariley@iu.edu
Study Locations
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-
Indiana
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Indianapolis, Indiana, United States, 46202
- Recruiting
- National Institute for Fitness and Sport
-
Contact:
- Zachary Riley
- Email: zariley@iu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between ages 18 and 45 years old (to avoid any changes in the developing brain, or with aging).
- Answer 'no' to questions 2 through 17 on the brain stimulation questionnaire as these factors can increase likelihood of adverse events with brain stimulation.
- No neurological damage, disease, or dysfunction (nerve damage, chronic pain disorders, diabetic neuropathy, epilepsy) that affect the upper limbs and limit the ability to complete the study, and/or compromise the objectives of the study
- No significant visual impairment that would prevent them from playing a video game.
Exclusion Criteria:
- Currently prescribed and taking stimulant medication (Adderall, Ritalin, Vyvanse, etc.)
- Consumption of over-the-counter stimulants such as caffeine or nicotine (coffee, soda, supplements, energy drinks, tobacco products, or other nicotine containing products such as gum, vape pens, etc...) 12 hours prior to entering the lab on the day of testing as this can directly affect cortical excitability. If a subject takes any of these substances 12 hours prior to the study visit they will be asked to reschedule for a later date.
- Have played a real stringed instrument in the last 12 months (e.g. guitar, bass, violin)
- Have played the videogame "Guitar Hero" on a traditional guitar controller in the last 12 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: rTMS stimulation group
this group will receive 15 minutes of repetitive transcranial magnetic stimulation of the motor cortex while seated quietly
|
in the arm/group descriptions
Other Names:
|
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Placebo Comparator: SHAM stimulation group
This group will have the same stimulating wand placed over the head, but at a distance far enough away as to not activate the cortical neurons.
|
in the arm/group descriptions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gaming outcome
Time Frame: 3 sessions, sessions 1 & 2 on the first day and session 3 on the follow-up day (next day)
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Primary outcome measures will include comparing video game performance (number of correct notes played, overstrums) across the three testing sessions.
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3 sessions, sessions 1 & 2 on the first day and session 3 on the follow-up day (next day)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortical Changes
Time Frame: 3 sessions, sessions 1 & 2 on the first day and session 3 on the follow-up day (next day)
|
Secondary outcome measures will include correlating cortical excitability with the amount of learning observed in video game performance.
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3 sessions, sessions 1 & 2 on the first day and session 3 on the follow-up day (next day)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zachary Riley, Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 30610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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