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Effect van hersenstimulatie op de benen.


- candidate number9081
- NTR NumberNTR2729
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-feb-2011
- Secondary IDsNL34235.044.10 CCMO
- Public TitleEffect van hersenstimulatie op de benen.
- Scientific TitleThe effect of NOn invasive brain stimulation on LOwer limb MOtor COntrol.
- ACRONYMNOLOMOCO
- hypothesisDual-hemisphere transcranial Direct Current Stimulation (tDCS) will result in a larger increase of the corticomotor excitability than uni-hemispere tDCS in healthy subjects and chronic stroke survivors.
- Healt Condition(s) or Problem(s) studiedStroke
- Inclusion criteriaThe inclusion criteria for the healthy subjects are:
1. Age > 18 years;
2. Able to walk on a treadmill.

The inclusion criteria for the stroke survivors are:
1. Age > 18 years;
2. Diagnosed with a hemiparesis as the result of a first ever, ischemic stroke;
3. Chronic stage: Time since stroke > 6 months;
4. Independent (score 4 to 5 on the functional ambulation classification) walkers with a clear walking impairment (asymmetry, reduced knee flexion during swing);
5. A stable medical condition;
6. A physical condition which allows for 3 minutes of walking;
7. Sufficient cognitive abilities (Mini-Mental State Examination ≥ 22);
8. Sufficient communication abilities (Utrechtse Communicatie Onderzoek ≥ 3).
- Exclusion criteria1. History of cardiac arrhythmias;
2. History of skin diseases that could result in irritation of the head skin underneath the electrodes;
3. Metallic implants in the brain;
4. Presence of cardiac pacemakers, cochlear implant or implanted brain electrodes;
5. Unexplained head aches;
6. Use medications that form a relative hazard for application of TMS due to a seizure threshold lowering potential;
7. Use medications that alters the cortical excitability;
8. (Possibility) of pregnancy;
9. Used any illegal drugs in the last month;
10. Had spinal surgery, or have drains in their spinal cord or ventricles;
11. Current orthopedic problems;
12. Other neurological disorders;
13. Chronic joint pain;
14. A history of cardiac conditions that interfere with physical load;
15. Severe depression.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-feb-2011
- planned closingdate1-jul-2011
- Target number of participants20
- InterventionstDCS will be applied over the leg motor cortex of the subjects in 3 sessions. In each of the three experimental sessions a different form of stimulation will be applied being uni-hemisphere anodal stimulation, dual-hemisphere stimulation or sham (placebo) stimulation. The tDCS will be applied for 10 minutes and different tests will be performed before (baseline) and after the stimulation (post) to assess the effects of the stimulation condition.
- Primary outcomeThe main study parameter is the relative change in single pulse Motor Evoked Potential (MEP) of the Tibialis Anterior and Vastus Lateralis at the post measurements compared to the baseline measurement.
- Secondary outcomeSecondary parameters are change in intermuscular coherence between the Vastus Lateralis and Biceps Femoris, intramuscular coherence of the Tibialis Anterior, change in propulsion of the paretic leg, change in basic gait parameters, change in H-reflex of the Soleus, change in reciprocal Ia inhibition of the soleus and change in D2 inhibition at the post measurements compared to baseline. Other parameters are the leg portion of the Fugl Meyer score, the 10 m walk test and the motricity index.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Edwin Asseldonk, van
- CONTACT for SCIENTIFIC QUERIES Edwin Asseldonk, van
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD7-feb-2011 - 14-feb-2011


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