- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447882
Unilateral M1 Anodal tDCS to Enhance Learning in a Gross Movement Videogame Task
Study Overview
Detailed Description
The study will utilize a between-subjects, SHAM controlled design. Subjects will be randomly selected to receive either SHAM (n=26) or a-tDCS (n=26) stimulation and will be blinded to their condition throughout testing.
Subjects will complete a total of two testing sessions (two study visits or days), separated by ~24 hours. Both sessions will have the subject play the videogame "Beat Saber", with a single song done for several trials as pre- and post-assessments. The first session will contain a 20-minute practice/stimulation block where subjects practice playing a song on Beat Saber while receiving either "active" or "inactive" stimulation of the motor cortex. The first session will last approximately 75 to 90 minutes whereas the second session will last approximately 15 to 20 minutes.
After providing informed consent, the subject will be given basic instructions by the researchers on how to use the VR headset and controller. Subjects will then be allowed to play the test song one time on the video game as a familiarization trial. The test song is approximately 4 minutes in length. Upon completing the familiarization trial, the subjects will then perform 2 more test song trials with 3-minute rest between each to minimize fatigue. The performance of these two trials will be averaged and that will serve as the pre-assessment measure.
After the pre-assessment, the skull will be measured and researchers will follow standard procedures for determining the correct stimulation spot for the index finger muscle, the first dorsal interosseus (FDI), which is a common muscle used in tDCS due to the large cortical representation. Following that, electrodes will be placed for stimulation and the 20 minute practice period will begin.
The practice phase will consist of performing 3 practice test song trials while concurrently receiving a-tDCS or SHAM. A Soterix 1x1 tDCS unit will be used to deliver anodal current through M1, of the opposite hemisphere to the VR controller hand, with a 30-second ramp up to 1 mA followed by 20 minutes of continuous stimulation in the a-tDCS condition. The SHAM condition will simulate stimulation by administering a 30 second ramp up to 1 mA followed by an immediate shut off. When the 20-minute practice session concludes, the tDCS electrodes will be removed and the subject will repeat the same procedures (2 trials) as the pre-assessment, and this will be considered the post-assessment.
In a second session, the subject will visit the lab for a brief follow-iup by completing 2 song trials, the exact same as the pre- and post-assessment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: zachary riley
- Phone Number: 765-215-1487
- Email: zariley@iu.edu
Study Locations
-
-
Indiana
-
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:
· Healthy adults between the ages 18-45
Answer 'no' to questions 2 through 18 on the tDCS checklist as these factors can increase likelihood of adverse events with tDCS (Appendix 1)
- No neurological damage, disease, or dysfunction (nerve damage, chronic pain disorders, diabetic neuropathy) that affect the upper limbs.
- No significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study
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 session 1 they will be asked to reschedule for a later date.
- Have played the game Beat Saber on a Virtual Reality Headset 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: tDCS
Participants will receive 20 minutes of continuous brain stimulation to M1. Stimulation will begin with a 30 second ramp up to 1mA and will include a 30 second ramp down at the end of the 20 minute period.
|
Soterix 1X1 tDCS stimulation device
|
|
Sham Comparator: SHAM
Participants receive no continuous stimulation.
The sham condition will be simulated by incorporating a 30 second ramp up to 1mA followed by an immediate shut-off.
|
Soterix 1X1 tDCS stimulation device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total number of good hits
Time Frame: Day 1
|
Beat Saber is a virtual reality (VR) rhythm game where players use motion controllers to slice, with virtual sabers, colored blocks that fly toward them in time with electronic music.
The total number of good hits during the post-assessment game performance will be tallied and compared to the total number of good hits from the pre-assessment game performance.
|
Day 1
|
|
Total accuracy
Time Frame: Day 1
|
Beat Saber is a virtual reality (VR) rhythm game where players use motion controllers to slice, with virtual sabers, colored blocks that fly toward them in time with electronic music.
Total accuracy of the game performance during the post-assessment game will be tallied and compared to the total number of good hits from the pre-assessment game performance.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total number of good hits
Time Frame: Day 2
|
Beat Saber is a virtual reality (VR) rhythm game where players use motion controllers to slice, with virtual sabers, colored blocks that fly toward them in time with electronic music.
The total number of good hits during the post-assessment game performance will be tallied.
|
Day 2
|
|
Total accuracy
Time Frame: Day 2
|
Beat Saber is a virtual reality (VR) rhythm game where players use motion controllers to slice, with virtual sabers, colored blocks that fly toward them in time with electronic music.
Total accuracy of the game performance during the post-assessment game will be tallied.
|
Day 2
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zachary Riley, Indiana University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26132
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
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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