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The brain and motor skills.


- candidate number10547
- NTR NumberNTR3153
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-nov-2011
- Secondary IDsP12-01 METC University of Twente
- Public TitleThe brain and motor skills.
- Scientific TitleContributions of the Supplementary Motor Area and the Pre-Motor Cortext to skilled sequential action: A TMS study.
- ACRONYM
- hypothesisThe study aims to converge the cognitive and neural domains and their respective models of sequential action in order to better understand the foundations of skilled sequential action. We hypothesize that the reaction and associative modes from the cognitive domain can be mapped onto PMC function, due to the continued need for stimuli. Conversely, the chunking mode seems to relate to SMA functioning, due to the highly internalized triggering of movement.
- Healt Condition(s) or Problem(s) studiedSequential action, Motor skill, Supprelementary motor area, Pre-motor cortex, TMS
- Inclusion criteriaSubjects can be included in the study if the meet the following criteria:
1. Subject is between 18 years of age or older;
2. Subject is right handed (as indicated b the Annett Handedness Inventory, see appendix).
- Exclusion criteriaSubjects will be excluded from the study if they have any of the contraindications referred to in the TMS screening questionnaire (Rossi et al., 2009; see appendix), which are:
1. Have a personal history of epilepsy;
2. Have a lesion in the brain, be it vascular, traumatic, tumoral, infectious or metabolic;
3. Have hearing problems;
4. Might be pregnant;
5. Have metal objects in their brain/skull;
6. Have a cochlear implant, implanted brain electrodes or pacemaker;
7. Suffer from a severe medical condition;
8. Use medications that form a relative hazard for application of TMS due to a seizure threshold lowering potential;
9. Had spinal surgery, or have drains in their spinal cord or ventricles;
10. Have used any illegal drugs in the last month.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate30-jun-2012
- Target number of participants60
- Interventions20min 1Hz rTMS applied to either PMC or SMA, or sham-stimulation (= control group).
- Primary outcomeResponse times on the motor task.
- Secondary outcomeAccuracy on the motor task (= discrete sequence production task).
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Marit Ruitenberg
- CONTACT for SCIENTIFIC QUERIES Marit Ruitenberg
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Organization for Scientific Research (NWO)
- PublicationsN/A
- Brief summaryRationale:
The ability to execute movements in a fixed sequential order and thus to develop sequencing skills is fundamental to human behaviour. Sequential skills have often been studied in the domains of cognitive psychology as well as neurology, and models on the production of such skill have been developed in both domains. Cognitive psychology has distinguished three modes of sequence execution, namely the reaction mode, the associative mode and the chunking mode. Regarding the neural domain, two brain areas have been found to be differently involved in sequential behaviour: the premotor cortex (PMC) is thought to be responsible for externally guided and/or triggered behaviour, while the supplementary motor area (SMA) is involved in internally guided (i.e., self-initiated) behaviour. The present study aims to converge the cognitive and neural domains - and their respective models of sequential action - in order to better understand the foundations of skilled sequential action. We hypothesize that the reaction and associative modes can be mapped onto PMC function, due to the continued need for stimuli. Conversely, the chunking mode seems to relate to SMA functioning, due to the highly internalized triggering of movement.

Objective:
The main objective is to investigate the involvement of the supplementary motor area (SMA) and the premotor cortex (PMC) in skilled sequential action.

Study design:
Interventional study with a sham-controlled between-subject design.

Study population:
Sixty healthy right-handed volunteers, aged 18 years or older, who do not take pro-epileptogenic medication or drugs and do not have a personal history of epilepsy or first degree relatives of epilepsy patients.

Intervention:
Twenty minutes of 1 Hz repetitive transcranial magnetic stimulation (rTMS; 1200 pulses) targeted to either the supplementary motor area (SMA group) or the premotor cortex (PMC group), or twenty minutes of sham stimulation (control group).

Main study parameters/endpoints:
The main study parameter is the difference in response time on a motor sequencing task between subjects in three rTMS conditions (SMA, PMC, sham).
- Main changes (audit trail)
- RECORD17-nov-2011 - 13-apr-2012


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