StrokeNCT06110169
tDCS for Neurological Disability Among Subacute Stroke Survivors to Improve Multiple Domains in Quality of Life
A study testing Anodal Transcranial Direct Current Stimulation (Anodal tDCS) in people with Stroke and Stroke, Ischemic, run by Karthick Balasubramanian at 1 site in Saudi Arabia.
Trial summary
Background: tDCS is an emerging noninvasive brain stimulation that triggers neuroplastic changes in the brain. To enhance motor and executive function, tDCS modifies neuronal activity. Targeted effects of tDCS for physical and cognitive function might help in improving domains related to QoL among stroke survivors. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke, Stroke, Ischemic
- What is being tested?
- Anodal Transcranial Direct Current Stimulation (Anodal tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2023to Apr 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females between the age group of 40 to 75 years
- Acute first-ever unilateral infarction which is confirmed by MRI.
- Subacute stroke (Ischemic type) (>7 days to 3 months post stroke)
- Modified Ashworth scale < 2 in both upper and lower extremity
- Mini-Mental State Examination Score between18-23 on admission
- National Institutes of Health stroke scale score of >10 on admission
- Clear consciousness able to sign the informed consent
Who cannot join
- Sensorimotor cortical infarcts
- Epilepsy
- Diagnosed as hemorrhagic stroke
- Any neurological diseases other than stroke
- Any musculoskeletal injury affecting motor functions
- Any neuropsychiatric diseases
Show all 10Show fewer
- Any medically unstable condition due to Cardiovascular or respiratory illness.
- Severe medical diseases or other systemic illness like malignancy, end stage kidney, heart or liver failure
- Pregnancy, presence of metallic implants, pacemaker
- Hypersensitive patients, Non-Cooperative or unwilling Individuals
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
University Hospital, Jazan University
Jizan, 45142
Mohammed Mansour Alshehri, 009665053946253, moAlshehri@jazanu.edu.sa
Karthick Balasubramanian, 00966535721053, bkarthick@jazanu.edu.sa
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) for Neurological Disability Among Subacute Stroke Survivors to Improve Multiple Domains in Quality of Life (QoL): Randomized Controlled Trial Protocol
Background: tDCS is an emerging noninvasive brain stimulation that triggers neuroplastic changes in the brain. To enhance motor and executive function, tDCS modifies neuronal activity. Targeted effects of tDCS for physical and cognitive function might help in improving domains related to QoL among stroke survivors. Therefore, the primary goal of the current proposal is to fill the gaps in the literature by studying the effectiveness of patient-tailored tDCS on lifestyle parameters, and physical, behavior, and cognitive functions among stroke survivors, and understanding the mediated factors of domains related to QoL improvements.
Type of study: Multiple Randomized Controlled trials (RCTs) Methods: Multiple RCTs will be conducted for subacute stroke survivors (>7 days to 3 months post stroke) aged 40-75 years with National Institutes of Health stroke scale score of >10 and Mini-Mental State Examination Score between18-23 on admission. Anticipated 64 Participants will take part in a prospective, randomized, participant- and assessor-blinded, sham-controlled trial after voluntary consent. The participants will be randomly assigned at a ratio of 1:1 to receive either: 16 patient-tailored sessions of anodal tDCS or sham tDCS in addition to conventional rehabilitation. Battery driven tDCS will be applied at 2 mA intensity to the dorsolateral prefrontal cortex and primary motor cortex for 20 minutes. The primary endpoints of study will be differences in 36-Item Short Form Survey (SF-36) scores post intervention at 4 weeks. The secondary outcomes will include Stroke Specific Quality of Life Scale, Montreal cognitive assessment, Beck Anxiety Inventory, Fugl-Meyer Assessment and Barthel Index.
Results: SPSS software version 22 will be used to analyze the normal distribution of data and based on data normality, within group and between group actual differences will be calculated for all outcome measures to examine the main effects of the intervention. The level of significance will be set at 0.05
Read the detailed description
Ischemic stroke (IS) is a major health concern worldwide. There are approximately 29 stroke cases per 100,000 of population residing in Saudi Arabia annually. Stroke is the second leading cause of mortality and a major contributor to adult disability in Saudi Arabia. Two-thirds of stroke patients continue to have motor impairments that have an impact on daily activities and quality of life. Survivors may continue to require specialised therapy assistance for months or even years following a stroke. Lack of inpatient and community rehabilitation, long-term care, and community support services has a substantial influence on patients with non-acute phase of stroke, thus urgent and acute care is not the only part of care that needs to improve. To offer better results for patients with stroke, rehabilitation programmes, primary care teams, social care professionals, and larger community services must all contribute their time and effort. These requirements seek to delve into the broader and more immediate facets of stroke treatment. The recovery of motor function following IS depends on the initiation of rehabilitative training at an early stage.
Inter-hemispheric balance is disrupted after stroke, interfering with the recovery process. Motor functions depend on the modulation of inter-hemispheric inhibition between cortical areas via transcallosal projections and descending projections. Unilateral hemispheric damage reduces activity in the affected hemisphere while activity in the unaffected hemisphere increases, becoming more dominant. Hence recovery may relate to rebalancing of inter-hemispheric inhibition. The safe, portable and noninvasive brain stimulation method known as tDCS can modify the excitability of certain brain regions by changing the polarity of the neuronal membrane potentials using sponge electrodes. Transcranial brain stimulation (TBS), when used in conjunction with neurorehabilitation in the early subacute phase after IS (within the first 4 weeks after stroke onset), may promote quicker and better recovery by enhancing underlying neuroplastic processes, which may be more susceptible at this time. tDCS alters neuronal activity and induces neuroplastic changes in the brain to improve motor and executive performance. Multiple sessions of tDCS may be utilized to enhance rehabilitative outcomes and lessen symptom load across a variety of Stroke. The targeted effects of tDCS on physical and functional aspects may contribute to an improvement in QoL-related areas. In Saudi Arabia, there is a significant gap between evidence-based stroke medication and care. Stroke has been deemed a high priority illness by the Ministry of Health that requires better management Therefore, the main objective of the current proposal is to close the gaps in the literature by researching the effects of tailored tDCS on lifestyle variables, as well as on physical, behavioral, and cognitive functions in stroke survivors, and by figuring out the factors that mediate the effects of various domains on QoL.
- Conditions
- Stroke, Stroke, Ischemic
- Being tested
- Anodal Transcranial Direct Current Stimulation (Anodal tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
- 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.
Anodal Transcranial Direct Current Stimulation (Anodal tDCS)Device
Battery driven tDCS will be applied at 2 mA intensity to the dorsolateral prefrontal cortex and primary motor cortex for 20 minutes.
Sham Transcranial Direct Current Stimulation (tDCS)Device
Participants will receive 20 minutes of sham anodal tDCS
| Study group | Role | What they receive |
|---|---|---|
| Group A (anodal tDCS) | Experimental | Participants will receive 20 minutes of anodal tDCS Receives: Device: Anodal Transcranial Direct Current Stimulation (Anodal tDCS) |
| Group B (sham tDCS) | Sham comparator | Participants will receive 20 minutes of sham anodal tDCS Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 will be used to measure overall health status
The SF-36 is an indicator of overall health status consisting of 10 Items. SF-36 is well validated and the reliability exceeds 0.80 in most studies. The score range is between 0-100, lower score indicate more disability. The sections of SF-36 include Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning \& Mental health.
Measured: At the beginning and at the end of intervention at 4 weeks intervention
Secondary outcomes (5)
Fugl-Meyer Assessment will be used to evaluate the physical performance of an individual following stroke.
The Fugl-Meyer Assessment is a reliable, multi-item, performance-based impairment index. It is categorized into 4 different domains, that is, motor function, joint range of motion, sensory function, balance and joint pain. Each domain contains multiple items scored on a three-point ordinal scale. The motor domain items evaluate movement coordination and reflex activity of the upper extremity and lower extremity joints. The upper extremity motor score ranges from 0 to 66, the lower extremity motor score range varies from 0 to 34 (total motor score of 100 points). Light touch and pain constitute sensory domains with the total score ranging between 0 and 24 (0 -12 for upper and lower extremity each), passive range of motion and joint pain scores range from 0 to 44 (0 -24 for upper extremity \& 0-20 for lower extremity
Measured: At the beginning and at the end of intervention at 4 weeks intervention
Montreal cognitive assessment will be sued to assess the cognitive domains
The Montreal cognitive assessment is a brief screening tool for cognitive domains providing a quick assessment of the global cognitive state of an individual in a short period of time. It includes the assessment of short-term memory, executive functions, visuospatial abilities, language, attention, concentration, working memory, and temporal and spatial orientation. Memory testing is done by a delayed recall of 5 nouns learned in 2 trials
Measured: At the beginning and at the end of intervention at 4 weeks intervention
Stroke-specific quality of life will be used to evaluate the Quality of life of individuals following stroke
Stroke-specific quality of life is a standardized, reliable (reliability coefficient 0.92), validated scale that specifically measures the quality of life of individuals that have had a stroke. The scale consists of 12 items grouped into physical and psychological subscales and 49 items, a 1 to 5 point range is used for scoring each item. The total range of scores vary from 49 to 245. The lowest score indicates poor quality of life he change score of an individual patient has to reach 5.9, 4.0, and 5.3 on the 3 subscales to indicate a true change. The mean change scores of a group of patients with stroke on these subscales should reach the lower bound of CID ranges of 1.5 (6.3% scale width), 1.2 (6.0% scale width), and 1.2 (6.0% scale width) to be regarded as clinically important change
Measured: At the beginning and at the end of intervention at 4 weeks intervention
Beck Anxiety Inventory used to assess post stroke depression
The sensitivity of the self-rated scales varied between 80% and 90%, while the specificity is estimated about 60%. The instrument is widely used to assess post stroke depression
Measured: At the beginning and at the end of intervention at 4 weeks intervention
Barthel Index used to measure disability/activities of daily living
Barthel index has excellent validity and reliability to measure disability/activities of daily living (ADL) and is widely used as outcome for stroke rehabilitation
Measured: At the beginning and at the end of intervention at 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karthick Balasubramanian
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Karthick Balasubramanian, University of Jazan
- Investigators
- Mohammed Mansour Alshehri, PhD, Principal investigator, Assistant professor, Department of Physical Therapy, Jazan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110169
- Sponsor's protocol ID
- tDCS for stroke survivors
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alqahtani BA, Alenazi AM, Hoover JC, Alshehri MM, Alghamdi MS, Osailan AM, Khunti K. Incidence of stroke among Saudi population: a systematic review and meta-analysis. Neurol Sci. 2020 Nov;41(11):3099-3104. doi: 10.1007/s10072-020-04520-4. Epub 2020 Jun 20.
PubMed 32564272Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
PubMed 24505342Winters C, van Wegen EE, Daffertshofer A, Kwakkel G. Generalizability of the Proportional Recovery Model for the Upper Extremity After an Ischemic Stroke. Neurorehabil Neural Repair. 2015 Aug;29(7):614-22. doi: 10.1177/1545968314562115. Epub 2014 Dec 11.
PubMed 25505223Cassidy JM, Cramer SC. Spontaneous and Therapeutic-Induced Mechanisms of Functional Recovery After Stroke. Transl Stroke Res. 2017 Feb;8(1):33-46. doi: 10.1007/s12975-016-0467-5. Epub 2016 Apr 25.
PubMed 27109642Divya M, Narkeesh A. Therapeutic Effect of Multi-Channel Transcranial Direct Current Stimulation (M-tDCS) on Recovery of Cognitive Domains, Motor Functions of Paretic Hand and Gait in Subacute Stroke Survivors-A Randomized Controlled Trial Protocol. Neurosci Insights. 2022 Mar 30;17:26331055221087741. doi: 10.1177/26331055221087741. eCollection 2022.
PubMed 35392020
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) for Neurological Disability Among Subacute Stroke Survivors to Improve Multiple Domains in Quality of Life (QoL): Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT06110169
- Acronym / sponsor ID
- tDCS for stroke survivors
- Conditions
- Stroke, Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Karthick BalasubramanianOther government
- Study start
- Nov 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 31 Oct 2023 (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.
Background: tDCS is an emerging noninvasive brain stimulation that triggers neuroplastic changes in the brain. To enhance motor and executive function, tDCS modifies neuronal activity. Targeted effects of tDCS for physical and cognitive function might help in improving domains related to QoL among stroke survivors. Therefore, the primary goal of the current proposal is to fill the gaps in the literature by studying the effectiveness of patient-tailored tDCS on lifestyle parameters, and physical, behavior, and cognitive functions among stroke survivors, and understanding the mediated factors of domains related to QoL improvements.
Type of study: Multiple Randomized Controlled trials (RCTs) Methods: Multiple RCTs will be conducted for subacute stroke survivors (>7 days to 3 months post stroke) aged 40-75 years with National Institutes of Health stroke scale score of >10 and Mini-Mental State Examination Score between18-23 on admission. Anticipated 64 Participants will take part in a prospective, randomized, participant- and assessor-blinded, sham-controlled trial after voluntary consent. The participants will be randomly assigned at a ratio of 1:1 to receive either: 16 patient-tailored sessions of anodal tDCS or sham tDCS in addition to conventional rehabilitation. Battery driven tDCS will be applied at 2 mA intensity to the dorsolateral prefrontal cortex and primary motor cortex for 20 minutes. The primary endpoints of study will be differences in 36-Item Short Form Survey (SF-36) scores post intervention at 4 weeks. The secondary outcomes will include Stroke Specific Quality of Life Scale, Montreal cognitive assessment, Beck Anxiety Inventory, Fugl-Meyer Assessment and Barthel Index.
Results: SPSS software version 22 will be used to analyze the normal distribution of data and based on data normality, within group and between group actual differences will be calculated for all outcome measures to examine the main effects of the intervention. The level of significance will be set at 0.05
Detailed description
Ischemic stroke (IS) is a major health concern worldwide. There are approximately 29 stroke cases per 100,000 of population residing in Saudi Arabia annually. Stroke is the second leading cause of mortality and a major contributor to adult disability in Saudi Arabia. Two-thirds of stroke patients continue to have motor impairments that have an impact on daily activities and quality of life. Survivors may continue to require specialised therapy assistance for months or even years following a stroke. Lack of inpatient and community rehabilitation, long-term care, and community support services has a substantial influence on patients with non-acute phase of stroke, thus urgent and acute care is not the only part of care that needs to improve. To offer better results for patients with stroke, rehabilitation programmes, primary care teams, social care professionals, and larger community services must all contribute their time and effort. These requirements seek to delve into the broader and more immediate facets of stroke treatment. The recovery of motor function following IS depends on the initiation of rehabilitative training at an early stage.
Inter-hemispheric balance is disrupted after stroke, interfering with the recovery process. Motor functions depend on the modulation of inter-hemispheric inhibition between cortical areas via transcallosal projections and descending projections. Unilateral hemispheric damage reduces activity in the affected hemisphere while activity in the unaffected hemisphere increases, becoming more dominant. Hence recovery may relate to rebalancing of inter-hemispheric inhibition. The safe, portable and noninvasive brain stimulation method known as tDCS can modify the excitability of certain brain regions by changing the polarity of the neuronal membrane potentials using sponge electrodes. Transcranial brain stimulation (TBS), when used in conjunction with neurorehabilitation in the early subacute phase after IS (within the first 4 weeks after stroke onset), may promote quicker and better recovery by enhancing underlying neuroplastic processes, which may be more susceptible at this time. tDCS alters neuronal activity and induces neuroplastic changes in the brain to improve motor and executive performance. Multiple sessions of tDCS may be utilized to enhance rehabilitative outcomes and lessen symptom load across a variety of Stroke. The targeted effects of tDCS on physical and functional aspects may contribute to an improvement in QoL-related areas. In Saudi Arabia, there is a significant gap between evidence-based stroke medication and care. Stroke has been deemed a high priority illness by the Ministry of Health that requires better management Therefore, the main objective of the current proposal is to close the gaps in the literature by researching the effects of tailored tDCS on lifestyle variables, as well as on physical, behavioral, and cognitive functions in stroke survivors, and by figuring out the factors that mediate the effects of various domains on QoL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (anodal tDCS) | Experimental | Device: Anodal Transcranial Direct Current Stimulation (Anodal tDCS)Participants will receive 20 minutes of anodal tDCS |
| Group B (sham tDCS) | Sham comparator | Device: Sham Transcranial Direct Current Stimulation (tDCS)Participants will receive 20 minutes of sham anodal tDCS |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and Females between the age group of 40 to 75 years
- Acute first-ever unilateral infarction which is confirmed by MRI.
- Subacute stroke (Ischemic type) (>7 days to 3 months post stroke)
- Modified Ashworth scale < 2 in both upper and lower extremity
- Mini-Mental State Examination Score between18-23 on admission
Key exclusion criteria (10 listed)
- Sensorimotor cortical infarcts
- Epilepsy
- Diagnosed as hemorrhagic stroke
- Any neurological diseases other than stroke
- Any musculoskeletal injury affecting motor functions
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 |
|---|---|---|
| Anodal Transcranial Direct Current Stimulation (Anodal tDCS)Battery driven tDCS will be applied at 2 mA intensity to the dorsolateral prefrontal cortex and primary motor cortex for 20 minutes. | Device | Group A (anodal tDCS) |
| Sham Transcranial Direct Current Stimulation (tDCS)Participants will receive 20 minutes of sham anodal tDCS | Device | Group B (sham tDCS) |
Primary outcome
SF-36 will be used to measure overall health status
Time frame: At the beginning and at the end of intervention at 4 weeks intervention
The SF-36 is an indicator of overall health status consisting of 10 Items. SF-36 is well validated and the reliability exceeds 0.80 in most studies. The score range is between 0-100, lower score indicate more disability. The sections of SF-36 include Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning \& Mental health.
5 secondary outcomes
Fugl-Meyer Assessment will be used to evaluate the physical performance of an individual following stroke.
Time frame: At the beginning and at the end of intervention at 4 weeks intervention
Montreal cognitive assessment will be sued to assess the cognitive domains
Time frame: At the beginning and at the end of intervention at 4 weeks intervention
Stroke-specific quality of life will be used to evaluate the Quality of life of individuals following stroke
Time frame: At the beginning and at the end of intervention at 4 weeks intervention
Beck Anxiety Inventory used to assess post stroke depression
Time frame: At the beginning and at the end of intervention at 4 weeks intervention
Barthel Index used to measure disability/activities of daily living
Time frame: At the beginning and at the end of intervention at 4 weeks intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Background: PubMed 32564272Alqahtani BA, Alenazi AM, Hoover JC, Alshehri MM, Alghamdi MS, Osailan AM, Khunti K. Incidence of stroke among Saudi population: a systematic review and meta-analysis. Neurol Sci. 2020 Nov;41(11):3099-3104. doi: 10.1007/s10072-020-04520-4. Epub 2020 Jun 20.
- Background: PubMed 24505342Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Background: PubMed 25505223Winters C, van Wegen EE, Daffertshofer A, Kwakkel G. Generalizability of the Proportional Recovery Model for the Upper Extremity After an Ischemic Stroke. Neurorehabil Neural Repair. 2015 Aug;29(7):614-22. doi: 10.1177/1545968314562115. Epub 2014 Dec 11.
- Background: PubMed 27109642Cassidy JM, Cramer SC. Spontaneous and Therapeutic-Induced Mechanisms of Functional Recovery After Stroke. Transl Stroke Res. 2017 Feb;8(1):33-46. doi: 10.1007/s12975-016-0467-5. Epub 2016 Apr 25.
- Background: PubMed 35392020Divya M, Narkeesh A. Therapeutic Effect of Multi-Channel Transcranial Direct Current Stimulation (M-tDCS) on Recovery of Cognitive Domains, Motor Functions of Paretic Hand and Gait in Subacute Stroke Survivors-A Randomized Controlled Trial Protocol. Neurosci Insights. 2022 Mar 30;17:26331055221087741. doi: 10.1177/26331055221087741. eCollection 2022.
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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.
Mohammed Mansour Alshehri, PhD principal investigator
Assistant professor, Department of Physical Therapy, Jazan 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 Anodal Transcranial Direct Current Stimulation (Anodal tDCS) in people with Stroke and Stroke, Ischemic, run by Karthick Balasubramanian at 1 site in Saudi Arabia.
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 7 inclusion and 10 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 2 Nov 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 Saudi Arabia. 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?
Contact Mohammed Mansour Alshehri, PhD (0096503946253, moAlshehri@jazanu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 will be used to measure overall health status (time frame: At the beginning and at the end of intervention at 4 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110169, which also lists 5 linked publications.
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 2 Nov 2023.