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Effect van hersenstimulatie op de benen.

The effect of NOn invasive brain stimulation on LOwer limb MOtor COntrol.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29069
Enrollment
20
Registered
2011-02-07
Start date
2011-02-15
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

tDCS 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 sti

Sponsors

University of Twente
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
The 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

MeasureTime frame
Secondary 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.

Contacts

Public ContactEdwin Asseldonk, van

Postbus 217

e.h.f.vanasseldonk@utwente.nl+31 (0)53 4892446

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)