Stroke, IschemicNCT04770363
Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Stroke, Ischemic and Stroke, Acute, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke, Acute, Stroke, Lacunar
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 20 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Ischemic, Stroke, Acute, Stroke, Lacunar, Hemiparesis, Hemiplegia, Motor Activity
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Medical subject headings
- Ischemic Stroke, Stroke, Stroke, Lacunar, Paresis, Hemiplegia, Motor Activity, Muscle Spasticity, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Also called (tDCS)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 Month
Secondary outcomes (2)
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.
Measured: Assessed for one time during participant recruitment
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.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Feb 2021
- Primary completion30 May 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nema Mohamed, PHD Prof, Principal investigator, Faculty of Science - Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770363
- Sponsor's protocol ID
- 0106522
- Status last verified
- Jun 2021
- First submitted
- 22 Feb 2021
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04770363
- Acronym / sponsor ID
- 0106522
- Conditions
- Stroke, Ischemic, Stroke, Acute, Stroke, Lacunar, Hemiparesis, Hemiplegia, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bihemispheric Stimulation Group | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)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). |
| Unihemispheric Stimulation Group | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)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. |
| Sham Group | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: (tDCS)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. | Device | Bihemispheric Stimulation Group, Sham Group, Unihemispheric Stimulation Group |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: 1 Month
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)
Time frame: 1 Month
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
Time frame: 1 Month
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.
2 secondary outcomes
The National Institutes of Health Stroke Scale, NIH Stroke Scale (NIHSS)
Time frame: Assessed for one time during participant recruitment
Berg Balance Scale
Time frame: 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nema Mohamed, PHD Prof principal investigator
Faculty of Science - Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Stroke, Ischemic and Stroke, Acute, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: 1 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.