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Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients

Primary Purpose

Stroke, Ischemic, Stroke, Acute, Stroke, Lacunar

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Those patients had stroke in the last 3 months.
  • Maximum with NIH stroke score less than 25.

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.

Sites / Locations

  • Ethics Committee - Alexandria Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Bihemispheric Stimulation Group

Unihemispheric Stimulation Group

Sham Group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

The National Institutes of Health Stroke Scale, NIH Stroke Scale (NIHSS)
to objectively assess the impairment caused by a stroke, score ranges from 0-42. Higher scores indicate worse outcome and severity. 0 is normal state of any participant.
Berg Balance Scale
To assess the body balance and rısk of fall within the upper and lower extremities, The test is scored using a 5-point ordinal scale (0-4) with detailed descriptors for each score. 0 indicates inability to obtain the task and 4 ability to fully obtain the task. Higher scores indicate good outcome. The total score ranges from 0 to 56.

Full Information

First Posted
February 22, 2021
Last Updated
March 24, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04770363
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
June 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Stroke, Acute, Stroke, Lacunar, Hemiparesis, Hemiplegia, Motor Activity, Spastic, Spasticity, Muscle, Hemiplegic Gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bihemispheric Stimulation Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Unihemispheric Stimulation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
(tDCS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA)
Description
To assess the upper and lower extremities, motor and sensory recovery assessment. Maximal attainable score is 226, means a good and functional physical state.
Time Frame
1 Month
Title
Modified Ashworth Scale (MAS)
Description
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.
Time Frame
1 Month
Title
Brain-Derived Neurotrophic Factor (BDNF) concentration
Description
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.
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
The National Institutes of Health Stroke Scale, NIH Stroke Scale (NIHSS)
Description
to objectively assess the impairment caused by a stroke, score ranges from 0-42. Higher scores indicate worse outcome and severity. 0 is normal state of any participant.
Time Frame
Assessed for one time during participant recruitment
Title
Berg Balance Scale
Description
To assess the body balance and rısk of fall within the upper and lower extremities, The test is scored using a 5-point ordinal scale (0-4) with detailed descriptors for each score. 0 indicates inability to obtain the task and 4 ability to fully obtain the task. Higher scores indicate good outcome. The total score ranges from 0 to 56.
Time Frame
1 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nema Mohamed, PHD Prof
Organizational Affiliation
Faculty of Science - Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ethics Committee - Alexandria Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt

12. IPD Sharing Statement

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Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients

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