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)

Copenhagen University Department of Nutrition and Exercise

Copenhagen, Denmark

Department of Neurology, Herlev Gentofte Hospital

Herlev, Denmark

Danish Research Centre for Magnetic Resonance

Hvidovre, Denmark

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NCT05355831


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