Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients

NCT04770363 | Completed DMC FDA Device

• 1 other identifier: 0106522
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial to study the effect of tDCS in participants with subacute ischemic stroke, the study participants will be randomly assigned into three groups; bihemispheric, unihemispheric and sham group.

Conditions

Stroke, Ischemic; Stroke, Acute; Stroke, Lacunar; Hemiparesis; Hemiplegia; Motor Activity; Spastic; Spasticity, Muscle; Hemiplegic Gait

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment (FMA)

  To assess the upper and lower extremities, motor and sensory recovery assessment. Maximal attainable score is 226, means a good and functional physical state.

  1 Month

• Modified Ashworth Scale (MAS)

  To assess the spasticity within the upper and lower extremities, score ranges from 0-4 with 5 choices. 0 indicates no resistance and 4 indicates rigidity. Higher scores indicate worse outcome.

  1 Month

• Brain-Derived Neurotrophic Factor (BDNF) concentration

  is assessed pre and post-treatment for all of the participants using (ELISA) molecular test, the difference between pre and post-treatment will be only assessed, no normal range is quantified.

  1 Month

Secondary Outcomes (2)

• The National Institutes of Health Stroke Scale, NIH Stroke Scale (NIHSS)

  Assessed for one time during participant recruitment

• Berg Balance Scale

  1 Month

Study Arms (3)

Bihemispheric Stimulation Group

EXPERIMENTAL

The first group tDCS bihemispheric stimulation consisted of 20 minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex M1 (C3 and C4 of the international 10 -20 EEG electrode system).

Device: Transcranial Direct Current Stimulation (tDCS)

Unihemispheric Stimulation Group

EXPERIMENTAL

The second group unilateral stimulation, the anode placed over the ipsilesional motor cortex M1 (C3 or C4 of the international 10 -20 EEG electrode system) and the cathode over contralesional supraorbital bone.

Device: Transcranial Direct Current Stimulation (tDCS)

Sham Group

SHAM COMPARATOR

The third sham group, the anode placed over the ipsilesional motor cortex M1 (C3 or C4 of the international 10 -20 EEG electrode system) and the cathode over contralesional supraorbital bone, but delivering no current.

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

Transcranial direct current stimulation (tDCS) is an emerging non-invasive brain stimulation technique which has been utilized in examining cortical function in healthy subjects and also showed significant outcome in neurological rehabilitation. A safe, portable, noninvasive painless, reversible, selective and focal brain stimulation technique, applied by sponge electrodes over the scalp. tDCS is capable of modulating the excitability of targeted brain zones through delivering a sustained direct current (DC), showed altering neuronal membrane potentials based on the polarity of the current. Researchers demonstrated modulating effects of anodal (increases cortical excitability) and cathodal (decreases cortical excitability) tDCS on brain tissue. The expected effects of tDCS brain stimulation exceeds the duration. Animal studies showed neuronal depolarization and increasing neuronal excitability of the anodal stimulation, and opposite results with cathodal stimulation.

Also known as: (tDCS)

Bihemispheric Stimulation Group; Sham Group; Unihemispheric Stimulation Group

Eligibility Criteria

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

You may qualify if:

• Those patients had stroke in the last 3-6 months.
• Subcortical stroke of middle cerebral artery (MCA), caused unilateral hemiplegia.
• National institute of health stroke scale (NIHSS) motor deficits section with score 2 to 15.

You may not qualify if:

• Patient with second onset of stroke or history of Transient ischemic attack (TIA)
• Metallic Implant or heart pacemakers.
• Primary cerebral or subarachnoid hemorrhagic stroke.
• Seizure or epilepsy or history of epilepsy at the family.
• Intracranial abscess or brain tumor.
• Cardiovascular disease myocardial infarction, heart failure (unstable cardiac status).
• Atrial Fibrillation or paroxysmal AF in the last 30 days.
• Congenital heart diseases.
• Presence of any other neurological or psychiatric disorder.
• Cognitive/consciousness disorders.
• Oher conditions should be excluded (e.g. tumor, cancer, rheumatologic, Lung disease related to infection, renal/ hepatic diseases, deep venous thrombosis and autoimmune diseases).
• Speech disorders (Dysarthria \& Aphasia).
• NIH Stroke score above 25, will be excluded.
• Patients who underwent thrombolytic therapy or any vascular interventions.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Ethics Committee - Alexandria Faculty of Medicine

Alexandria, 21131, Egypt

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Stroke, Lacunar; Paresis; Hemiplegia; Motor Activity; Muscle Spasticity; Gait Disorders, Neurologic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Small Vessel Diseases; Thrombotic Stroke; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Neurologic Manifestations; Signs and Symptoms; Paralysis; Behavior; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Nema Mohamed, PHD Prof

  Faculty of Science - Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor) To make sure that no bias should enter the assessment of the results, neither the patient nor the external assessor will be aware whether active tDCS will be applicated to a particular case. The patients don't know if which group they are participated in, bihemispheric, unihemispheric, of sham group, external assessor was recruited to assess patients after the intervention ended.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will participate into the study, each patient will undergo a detailed neurological examination through filling out a medical sheet questionnaire and checking the most common risk factors of stroke and other parameters. ActivaDose tDCS (USA), the only FDA cleared device available for tDCS will be used in the clinical study. Thirty patients will be allocated randomly into three group.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: February 1, 2021
• Primary Completion: May 30, 2021
• Study Completion: June 20, 2021
• Last Updated: March 27, 2023

Record last verified: 2021-06

Locations

EG (1)