StroketDCSNCT01601392
Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery
A study testing transcranial direct current stimulation (Anodal) and transcranial direct current stimulation (Cathodal) in people with Stroke, run by Dina Hatem Elhammady at 1 site in Egypt.
Trial summary
The purpose of this study will to compare the long-term effect of anodal versus cathodal transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients. Forty patients with subacute ischemic stroke will randomly assigned to one of three groups: Anodal, Cathodal and Sham. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- transcranial direct current stimulation (Anodal) and transcranial direct current stimulation (Cathodal)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2011to Jun 2012
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by magnetic resonance imaging (MRI)
- Accept to participate in the study
Who cannot join
- extensive infarction (taking all territories of middle cerebral artery)
- severe flaccid hemiplegia
- head injury
- Any other neurological disease other than stroke
- previous administration of tranquilizer
- patients who are unable to give informed consent because of severe aphasia, or cognitive deficit.
- Patients with no motor evoked response recorded from First Dorsal Interosseus (FDI) muscle of the affected hand
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial
The purpose of this study will to compare the long-term effect of anodal versus cathodal transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients. Forty patients with subacute ischemic stroke will randomly assigned to one of three groups: Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS), the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical excitability will be measured at baseline and after the 6th session in both hemispheres.
- Conditions
- Stroke
- Being tested
- transcranial direct current stimulation (Anodal), transcranial direct current stimulation (Cathodal), transcranial direct current stimulation (Sham)
- Keywords
- Ischemic stroke, direct current stimulation, motor threshold, National institutes of Health Stroke Scale, Barthel index scale, Measurement of motor power improvement
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (Anodal)Procedure or surgery
The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere.
transcranial direct current stimulation (Cathodal)Procedure or surgery
The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere.
transcranial direct current stimulation (Sham)Procedure or surgery
The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Not described Receives: Procedure: transcranial direct current stimulation (Anodal) |
| Cathodal tDCS | Active comparator | Not described Receives: Procedure: transcranial direct current stimulation (Cathodal) |
| Sham | Sham comparator | Not described Receives: Procedure: transcranial direct current stimulation (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor power improvement
improvement in the motor power of paretic patient as measured in one proximal and one distal muscle group testing in upper (shoulder abduction + hand grip) and lower limbs ( hip flexion + toes dorsiflexion).
Measured: 3 Months
Secondary outcomes (1)
Motor cortical excitability
The difference in the motor cortical excitability (RMT, AMT) before and after tDCS
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 posted18 May 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dina Hatem Elhammady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dina Hatem Elhammady, Assiut University
- Investigators
- Eman M Khedr, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601392
- Sponsor's protocol ID
- tDCS in stroke recovery
- Acronym
- tDCS
- Status last verified
- May 2012
- First submitted
- 11 May 2012
- Last updated
- 18 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01601392
- Acronym / sponsor ID
- tDCS / tDCS in stroke recovery
- Conditions
- Stroke
- Keywords
- Ischemic stroke, direct current stimulation, motor threshold, National institutes of Health Stroke Scale, Barthel index scale, Measurement of motor power improvement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dina Hatem ElhammadyUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 18 May 2012 (estimated)
- 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.
The purpose of this study will to compare the long-term effect of anodal versus cathodal transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients. Forty patients with subacute ischemic stroke will randomly assigned to one of three groups: Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS), the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical excitability will be measured at baseline and after the 6th session in both hemispheres.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Procedure: transcranial direct current stimulation (Anodal) |
| Cathodal tDCS | Active comparator | Procedure: transcranial direct current stimulation (Cathodal) |
| Sham | Sham comparator | Procedure: transcranial direct current stimulation (Sham) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by magnetic resonance imaging (MRI)
- Accept to participate in the study
Key exclusion criteria (7 listed)
- extensive infarction (taking all territories of middle cerebral artery)
- severe flaccid hemiplegia
- head injury
- Any other neurological disease other than stroke
- previous administration of tranquilizer
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 (Anodal)The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere. | Procedure or surgery | Anodal tDCS |
| transcranial direct current stimulation (Cathodal)The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere. | Procedure or surgery | Cathodal tDCS |
| transcranial direct current stimulation (Sham)The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere. | Procedure or surgery | Sham |
Primary outcome
Motor power improvement
Time frame: 3 Months
improvement in the motor power of paretic patient as measured in one proximal and one distal muscle group testing in upper (shoulder abduction + hand grip) and lower limbs ( hip flexion + toes dorsiflexion).
1 secondary outcome
Motor cortical excitability
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
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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.
Eman M Khedr, Professor principal investigator
Assiut 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 (Anodal) and transcranial direct current stimulation (Cathodal) in people with Stroke, run by Dina Hatem Elhammady 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 May 2012. 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?
Results are not available in the source record.
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?
Motor power improvement (time frame: 3 Months). 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 18 May 2012.