- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Zachary A Riley
- Telefoonnummer: 317-274-1487
- E-mail: zariley@iu.edu
Studie Locaties
-
-
Indiana
-
Indianapolis, Indiana, Verenigde Staten, 46202
- Werving
- National Institute for Fitness and Sport
-
Contact:
- Zachary Riley
- E-mail: zariley@iu.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
Andere namen:
|
|
Placebo-vergelijker: 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
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Gaming outcome
Tijdsspanne: 3 sessions, sessions 1 & 2 on the first day and session 3 on the follow-up day (next day)
|
Primary outcome measures will include comparing video game performance (number of correct notes played, overstrums) across the three testing sessions.
|
3 sessions, sessions 1 & 2 on the first day and session 3 on the follow-up day (next day)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cortical Changes
Tijdsspanne: 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.
|
3 sessions, sessions 1 & 2 on the first day and session 3 on the follow-up day (next day)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Zachary Riley, Professor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 30610
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .