Status:
RECRUITING
Patient-tailored Transcranial Direct Current Stimulation to Improve Stroke Rehabilitation
Lead Sponsor:
Christina Kruuse
Collaborating Sponsors:
Danish Research Centre for Magnetic Resonance
The Novo Nordic Foundation
Conditions:
Ischemic Stroke
Upper Extremity Hemiparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In a double-blinded sham-controlled study the effect of patient-tailored transcranial direct current stimulation during rehabilitation training will be examined.
Detailed Description
Approximately two thirds of stroke patients have reduced motor function which have a large impact on both activities of daily living and quality of life. Only 12-34% achieve full motor recovery. Ther...
Eligibility Criteria
Inclusion
- Patients -
- Age \>18 years
- Ischemic stroke confirmed by clinical and imaging criteria
- Hemiparesis including reduced upper-extremity function
- Location of stroke either cortically involving middle cerebral artery or the anterior cerebral artery circulation or subcortical (involving thalamus, basal ganglia).
- NIHSS score \>2 and \<8
- Modified Rankin Scale (mRS) ≤ 3
- Index of stroke within 4 weeks of inclusion
- Signed informed consent
- Patients -
Exclusion
- \>50% stenosis of extra- or intracranial artery as well as vascular malformations or aneurisms detected by brain CT-angiography.
- Exclusively ischemic stroke in spine, pons, brainstem, medulla or cerebellum.
- History of seizures, epilepsy, anxiety, dementia alcohol- or drug abuse.
- Prior serious head injury or neurosurgery
- Frequent severe headaches or migraine.
- Pregnancy or breastfeeding
- Current use of neuro-receptor/transmitter modulating medication, or medication interfering with seizure threshold (such as antiepileptic medication, some antidepressants, anxiety medication, antihistamines, stimulant drugs for attention deficit hyperactivity disorder).
- Pacemaker, implantable cardiac device unit (ICD-unit), metal fragments or other materials implanted not compatible with MRI (see appendix B).
- Claustrophobia
- Prior adverse effect to TDCS or Transcranial Magnetic Stimulation.
- Not able to provide informed consent.
- Terminally ill or short life expectancy.
- Healthy controls - Inclusion criteria:
- Age between \>18 years (matched to patients)
- Sex and age matched to patients
- Able bodied
- Have the ability to comply with all requirements of the study protocol, as determined by the investigator
- No history of stroke or dementia
- Eligible for MRI and TMS
- Healthy controls -
Key Trial Info
Start Date :
August 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05355831
Start Date
August 28 2022
End Date
December 1 2024
Last Update
July 11 2024
Active Locations (3)
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1
Copenhagen University Department of Nutrition and Exercise
Copenhagen, Denmark, 2200
2
Department of Neurology, Herlev Gentofte Hospital
Herlev, Denmark, 2730
3
Danish Research Centre for Magnetic Resonance
Hvidovre, Denmark, 2650