- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Zachary A Riley
- Telefonnummer: 317-274-1487
- E-mail: zariley@iu.edu
Studiesteder
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- National Institute for Fitness and Sport
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Kontakt:
- Zachary Riley
- E-mail: zariley@iu.edu
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: rTMS stimulation group
this group will receive 15 minutes of repetitive transcranial magnetic stimulation of the motor cortex while seated quietly
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in the arm/group descriptions
Andre navne:
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Placebo komparator: 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.
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in the arm/group descriptions
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gaming outcome
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Cortical Changes
Tidsramme: 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 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)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Zachary Riley, Professor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 30610
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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