Personalized brain stimulation to enhance stroke rehabilitation
Patient-tailored Transcranial Direct Current Stimulation to Improve Stroke Rehabilitation
This study is testing if personalized brain stimulation can help stroke patients with arm weakness recover better during their rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 3 sites (Copenhagen and 2 other locations) |
| Trial ID | NCT05355831 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of patient-tailored transcranial direct current stimulation (tDCS) during rehabilitation training for stroke patients with upper-extremity hemiparesis. It employs a double-blinded sham-controlled design to assess how individualized tDCS, guided by functional and structural MRI, can improve motor function post-stroke. The goal is to optimize the stimulation to target areas of the brain with residual neural activity, potentially leading to better rehabilitation outcomes. Clinical measures of motor improvement will be used to evaluate the effectiveness of this personalized approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have experienced an ischemic stroke within the last four weeks and have upper-extremity hemiparesis.
Not a fit: Patients with certain vascular conditions, severe neurological disorders, or those currently on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor recovery in stroke patients, improving their quality of life and independence.
How similar studies have performed: Previous studies have shown promise with non-invasive brain stimulation techniques, but this personalized approach using MRI-guided tDCS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients - Inclusion Criteria: 1. Age \>18 years 2. Ischemic stroke confirmed by clinical and imaging criteria 3. Hemiparesis including reduced upper-extremity function 4. Location of stroke either cortically involving middle cerebral artery or the anterior cerebral artery circulation or subcortical (involving thalamus, basal ganglia). 5. NIHSS score \>2 and \<8 6. Modified Rankin Scale (mRS) ≤ 3 7. Index of stroke within 4 weeks of inclusion 8. Signed informed consent Patients - Exclusion Criteria: 1. \>50% stenosis of extra- or intracranial artery as well as vascular malformations or aneurisms detected by brain CT-angiography. 2. Exclusively ischemic stroke in spine, pons, brainstem, medulla or cerebellum. 3. History of seizures, epilepsy, anxiety, dementia alcohol- or drug abuse. 4. Prior serious head injury or neurosurgery 5. Frequent severe headaches or migraine. 6. Pregnancy or breastfeeding 7. 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). 8. Pacemaker, implantable cardiac device unit (ICD-unit), metal fragments or other materials implanted not compatible with MRI (see appendix B). 9. Claustrophobia 10. Prior adverse effect to TDCS or Transcranial Magnetic Stimulation. 11. Not able to provide informed consent. 12. Terminally ill or short life expectancy. Healthy controls - Inclusion criteria: 1. Age between \>18 years (matched to patients) 2. Sex and age matched to patients 3. Able bodied 4. Have the ability to comply with all requirements of the study protocol, as determined by the investigator 5. No history of stroke or dementia 6. Eligible for MRI and TMS Healthy controls - Exclusion Criteria: 1. History of neurologic disease 2. History of cerebral haemorrhage or brain damage 3. Pregnancy 4. Pacemaker or other implanted electronic devices 5. Claustrophobia 6. Psychiatric disorder 7. Epilepsy or close relatives suffering from epilepsy 8. Migraine 9. Any contraindication to MRI or TMS
Where this trial is running
Copenhagen and 2 other locations
- Copenhagen University Department of Nutrition and Exercise — Copenhagen, Denmark (Recruiting)
- Department of Neurology, Herlev Gentofte Hospital — Herlev, Denmark (Recruiting)
- Danish Research Centre for Magnetic Resonance — Hvidovre, Denmark (Recruiting)
Study contacts
- Principal investigator: Christina Kruuse, MD, Prof — Herlev Gentofte Hospital, Department of Neurology
- Study coordinator: Christina Krusse, MD, Prof
- Email: christina.kruuse@regionh.dk
- Phone: +4538681233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.