RecruitingNot ApplicableNCT05355831
Patient-tailored Transcranial Direct Current Stimulation to Improve Stroke Rehabilitation
Sponsor
Christina Kruuse
Enrollment
22 participants
Start Date
Aug 28, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
In a double-blinded sham-controlled study the effect of patient-tailored transcranial direct current stimulation during rehabilitation training will be examined.
Eligibility
Min Age: 18 Years
Inclusion Criteria14
- 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
- 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
Exclusion Criteria21
- >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.
- History of neurologic disease
- History of cerebral haemorrhage or brain damage
- Pregnancy
- Pacemaker or other implanted electronic devices
- Claustrophobia
- Psychiatric disorder
- Epilepsy or close relatives suffering from epilepsy
- Migraine
- Any contraindication to MRI or TMS
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Interventions
DEVICEActive Transcranial Direct Current Stimulation
See arm/group description
DEVICESham stimulation
See arm/group description
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05355831
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