Patient-tailored Transcranial Direct Current Stimulation to Improve Stroke Rehabilitation

Launched by CHRISTINA KRUUSE · Apr 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people recover from a specific type of stroke called ischemic stroke, which can cause weakness in one side of the body, particularly affecting the arm. Researchers are looking at a treatment called transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain. The goal of this study is to see if using tDCS during rehabilitation training can improve recovery for patients. The trial is currently recruiting participants aged 18 and older who have experienced a stroke within the last four weeks, have some arm weakness, and meet certain health criteria.

Participants will be randomly assigned to receive either the active treatment or a "sham" treatment, which means they may not know if they are getting the real therapy. This helps ensure the results are reliable. If you or someone you know is interested, it's important to be eligible, which includes not having certain serious health issues or conditions that could interfere with the study. Throughout the trial, participants will work with researchers to monitor their progress and help improve their rehabilitation experience.

Gender

ALL

Eligibility 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