Clinical trial NCT04770363: Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients
Official title: Comparison Between the Effect of Unihemispheric and Bihemispheric Transcranial Direct Current Stimulation on Spasticity and Motor Outcome in Subacute Ischemic Stroke Patients: as Add on Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke, Acute
Stroke, Lacunar
Hemiparesis
Hemiplegia
Motor Activity
Spastic
Spasticity, Muscle
Hemiplegic Gait
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Despite the central origin of stroke affecting the primary motor cortex M1, majority of the rehabilitative techniques of physical therapy and occupational therapy practice depending peripheral methods for gaining motor functions. There is a great need to develop methods in order to improve the outcome of physical or medical rehabilitation and enhance long-term functional outcome. Many researches' work over the past several years have inspected the use of transcranial direct current stimulation (tDCS) to promote the advantageous effect of neurological rehabilitation.

The aim of This study Is to compare between the effect of unihemispheric and bihemispheric tDCS on the motor outcome, and spasticity in sub-acute ischemic stroke patients.

Thirty sub-acute ischemic stroke patients participated in the study, randomly assigned to one of three groups-tDCS bihemispheric or unihemispheric or sham group. Those patients had stroke in the last 3 months at maximum with NIH stroke score less than 25. ActivaDose tDCS (USA), the only FDA cleared device available for tDCS used in the clinical study to deliver noninvasive brain stimulation, consisted of 20 minutes of 2 mA in each session for twelve sessions three sessions per week. All participants received physiotherapy and rehabilitation therapy was tailored to meet all patients' deficits, and lasted a total of 45 minutes per day, 3 days per week for four weeks.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: 1 Month
measure: Modified Ashworth Scale (MAS)
timeFrame: 1 Month
measure: Brain-Derived Neurotrophic Factor (BDNF) concentration
timeFrame: 1 Month
Secondary outcomes:
measure: The National Institutes of Health Stroke Scale, NIH Stroke Scale (NIHSS)
timeFrame: Assessed for one time during participant recruitment
measure: Berg Balance Scale
timeFrame: 1 Month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Ethics Committee - Alexandria Faculty of Medicine
Study officials:
affiliation: Faculty of Science - Alexandria University
name: Nema Mohamed, PHD Prof
role: PRINCIPAL_INVESTIGATOR
References: