Patient-tailored Transcranial Direct Current Stimulation to Improve Stroke Rehabilitation

NCT05355831 | Recruiting DMC

• 1 other identifier: H-20036199
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

In a double-blinded sham-controlled study the effect of patient-tailored transcranial direct current stimulation during rehabilitation training will be examined.

Conditions

Ischemic Stroke; Upper Extremity Hemiparesis

Keywords

non-invasive brain stimulation; transcranial direct current stimulation; effective connectivity; functional connectivity; Fugl-Meyer Assessment; Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Pilot outcome

  Difference in Upper-extremity Fugl-Meyer Assessment (UE-FMA) score at end of treatment. Range 0-66.

  From baseline to four months

Secondary Outcomes (24)

• Change in upper-extremity function

  From baseline to four months

• Stroke severity

  From baseline to four months

• Stroke disability

  From baseline to four months

• ADL performance

  From baseline to four months

• Gait speed

  From baseline to four months

Other Outcomes (6)

• Brain Derived Neutrotrophic Factor (BDNF) genetic polymorphism

  Baseline

• Feasibility of intervention

  From baseline to four months

• TMS - motor evoked potential

  Baseline

Study Arms (2)

Active Transcranial Direct Current Stimulation

ACTIVE COMPARATOR

Anodal TDCS 1mV for 2x 20 minutes.

Device: Active Transcranial Direct Current Stimulation

Sham stimulation

SHAM COMPARATOR

2x 20 minutes of sham stimulation (30 sec ramp up, followed by current of 0 for 18.5 minutes followed by 30 sec ramp down).

Device: Sham stimulation

Interventions

Active Transcranial Direct Current Stimulation DEVICE

See arm/group description

Active Transcranial Direct Current Stimulation

Sham stimulation DEVICE

See arm/group description

Sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed informed consent

You may not qualify if:

• \>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.
• Age between \>18 years (matched to patients)
• Sex and age matched to patients
• Able bodied

Sponsors & Collaborators

• Christina Kruuse: lead
• Danish Research Centre for Magnetic Resonance: collaborator
• The Novo Nordic Foundation: collaborator
• University of Copenhagen: collaborator
• Lundbeck Foundation: collaborator

Study Sites (3)

Copenhagen University Department of Nutrition and Exercise

Copenhagen, 2200, Denmark

RECRUITING

Department of Neurology, Herlev Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

Danish Research Centre for Magnetic Resonance

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christina Kruuse, MD, Prof

  Herlev Gentofte Hospital, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Krusse, MD, Prof

CONTACT

+4538681233; christina.kruuse@regionh.dk

Mia Kolmos, MD

CONTACT

+4538681375; mia.kolmos@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator, Consultant Neurologist, Dept. Neurology, Herlev Hospital

Model Details: Intervention pilot- and feasibility trial

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: August 28, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

DK (3)