StrokeNCT05180929
Dual-tDCS and Anodal PMC tDCS Over the Contralesional Hemisphere on the Upper Limb Function in Stroke Patients
A study testing Dual M1-tDCS and a-tDCS over contralesional PMC in people with Stroke, run by Turki Abualait at 1 site in Saudi Arabia.
Trial summary
Background: Transcranial direct current stimulation (tDCS) has been gaining increasing interest as a potential therapeutic tool to improve upper extremity (UE) rehabilitation outcomes following stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Dual M1-tDCS and a-tDCS over contralesional PMC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Nov 2017to 14 Mar 2020
- 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
- First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (≥ 6 months).
- Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
- Mini Mental State Examination Score ≥ 24
Who cannot join
- History of epileptic seizures.
- Pre-stroke motor impairment(s) affecting UE.
- Presence of UE contractures or deformities.
- Botulinum toxin to UE muscles in the last 6 months.
- Presence of damaged skin on the scalp that would interfere with tDCS stimulation.
- Individuals with metallic implant in the brain or medical devices (i.e., cardiac pacemaker, deep brain stimulator, cochlear implants).
Show all 9Show fewer
- Use of CNS-affecting drugs.
- Additional neurological or psychiatric problem.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
BrainStim Lab, Imam Abdulrahman Bin Faisal University
Dammam, Eastern Province, 32210
About this study
Official title: The Comparative Effects of Dual-tDCS and Anodal Premotor tDCS Over the Contralesional Hemisphere on the Upper Limb Function and Manual Dexterity in Patients With Chronic Stroke: Single-blinded Randomized Controlled Trial
Background: Transcranial direct current stimulation (tDCS) has been gaining increasing interest as a potential therapeutic tool to improve upper extremity (UE) rehabilitation outcomes following stroke. Within the concept of interhemispheric inhibition (IHI), most tDCS studies have applied anodal ipsilesional and/or cathodal contralesional primary motor cortex (M1) tDCS to rebalance IHI and enhance motor recovery. However, compelling evidence suggests that an excitation/inhibition model is oversimplified, and the role of both hemispheres in the encoding of information during motor learning should be acknowledged. Moreover, multiple lines of evidence have demonstrated the potential relevance of contralesional premotor cortex (PMC) for recovery after M1 injury.
Objective: We are aiming to investigate and compare the effects of two tDCS montages at different cortical sites (Dual-M1 vs. a-tDCS over contralesional PMC) by measuring the clinical outcomes of the most affected UE in patients with chronic subcortical stroke.
Read more
Methods: 35 participants will be randomly assigned to 1 of 3 groups (Group A received dual- M1 tDCS, Group B received a-tDCS over contralesional PMC, and Group C received sham stimulation). tDCS will be applied using intensity of 2 mA for 20 min. (5 times/week) for 2 consecutive weeks. Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT) will be used to quantify the UE functional motor ability. Box and Block Test (BBT) will be used for gross manual dexterity and Nine Hole Peg Test (NHPT) will be used to measure fine hand dexterity. All measurements will be taken pre-treatment (T0) and post-treatment (T1) immediately after the 10th session, then 4 weeks after the end of stimulation period (T2) to assess the long-term effects.
Expected results: This study would verify whether enhancing the motor cortical hyperexcitability in the contralesional hemisphere has a beneficial on recovery of the paretic hand, or regaining the balance of transcallosal inhibitory circuits between the motor areas in both hemispheres has more positive effects on the motor outcomes . This study would also provide a predictive approach to enable realistic rehabilitation goal-setting by identifying the proper tDCS montage for patients with stroke depending on their impairment level.
Read the detailed description
This experimental study will be conducted in a sham-controlled, single-blinded randomized controlled design. The subjects will be recruited - by convenience sampling - from the outpatient population of different governmental hospitals in Eastern Province of Saudi Arabia. Neurologists, Physiatrists and Physical therapists will be contacted to recruit potential subjects and IRB-approved letter will be sent to them. The subjects will be screened to determine whether a potential participant is eligible to be enrolled in the study or not. Only the principal investigator (PI) will conduct the screening procedures, which include reviewing medical record, in-person interview and administration of Mini-Mental State Examination. All screening activities will take 15-20 min., and they will be performed in a private screening room. Enrollment will occur after verifying the eligibility and obtaining the signed written consent form. Participants will be enrolled in the study only if they met all the inclusion criteria, which are:
- Male or Female participants aged ≥ 18
- First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (≥ 6 months).
- Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE).
- Mini Mental State Examination Score ≥ 24.
All the participants were receiving conventional physical therapy and occupational therapy sessions (1-2 times/week).
The Exclusion Criteria included the following:
- History of epileptic seizures.
- Pre-stroke motor impairment(s) affecting UE.
- Presence of UE contractures or deformities.
- Botulinum toxin to UE muscles in the last 6 months.
- Presence of damaged skin on the scalp that would interfere with tDCS stimulation.
- Individuals with metallic implant in the brain or medical devices (i.e., cardiac pacemaker, deep brain stimulator, cochlear implants).
- Use of CNS-affecting drugs.
- Additional neurological or psychiatric problem.
- Pregnancy.
After enrollment, all participants will be scheduled to receive 10 sessions over two consecutive weeks (5 sessions/week). Each participant will be seen initially (1st visit) for about 90 min. to conduct all baseline measurements (T0), which will include clinical examinations using different standardized tests for upper limb function, and to conduct the experiment. The follow up sessions (8 sessions) will last for around 30 min. (10 min. for preparation and employing the electrodes + 20 min. for the stimulation). The 10th session will last for about 90 min. to carry out the measurement tests (T1) and to conduct the last stimulation session. The final visit will be scheduled to be 4 weeks after the 10th session to evaluate the long-term effects using the same measurement tests (T2).
All the participants will be blinded to the type of stimulation they received. The PI will take all the baseline measurements (T0), post-stimulation measurements immediately after the 10th session (T1), and long-term effects 4 weeks after the end of the stimulation period (T2). The PI will carry out all tDCS sessions as well.
All the participants will be randomly assigned, using opaque envelopes, to one of three groups:
- Group A (n=11) receive dual-tDCS
- Group B (n=13) receive a-tDCS over PMC in the contralesional hemisphere, and
- Group C (n=11) receive sham stimulation.
This study protocol has been approved by the IRB from the research ethics committee in Imam Abdulrahman Bin Faisal University.
- Conditions
- Stroke
- Being tested
- Dual M1-tDCS, a-tDCS over contralesional PMC, Sham tDCS
- Keywords
- tDCS, PMC, IHI, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual M1-tDCSDevice
In the M1- dual tDCS montage, the anodal electrode will be placed above ipsilesional M1 and the cathode will be positioned over contralesional M1.
a-tDCS over contralesional PMCDevice
In the anodal-tDCS for PMC, the anodal electrode will be placed over the contralesional PMC. The PMC is defined as being 2.5 cm anterior to the M1. The cathodal electrode will be positioned over the contralateral suborbital region
Sham tDCSDevice
For sham stimulation, there is no particular electrode configuration to be followed, thus, 6 participants will receive sham stimulation with the configuration will be used in group A, and 5 participants will receive sham stimulation with the configuration will be used in group B. By pressing the sham button, the current will automatically ramped up over 10 sec. till reaching 1 mA, then it will be decreased gradually over 30 seconds till turning off the apparatus. This is to ensure the typical initial itching sensation
| Study group | Role | What they receive |
|---|---|---|
| Dual-M1 tDCS | Experimental | In the M1- dual tDCS montage, the anodal electrode will be placed above ipsilesional M1 and the cathode will be positioned over contralesional M1. Receives: Device: Dual M1-tDCS |
| a-tDCS over contralesional PMC | Experimental | In the anodal-tDCS for PMC, the anodal electrode will be placed over the contralesional PMC. The PMC is defined as being 2.5 cm anterior to the M1. The cathodal electrode will be positioned over the contralateral suborbital region Receives: Device: a-tDCS over contralesional PMC |
| Sham tDCS | Sham comparator | For sham stimulation, there is no particular electrode configuration to be followed, thus, 6 participants will receive sham stimulation with the configuration will be used in group A, and 5 participants will receive sham stimulation with the configuration will be used in group B. By pressing the sham button, the current will automatically ramped up over 10 sec. till reaching 1 mA, then it will be decreased gradually over 30 seconds till turning off the apparatus. This is to ensure the typical initial itching sensation Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline 'Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)' at 4 weeks
the most frequently used outcome measure when assessing UE function after stroke within the research context (Santisteban et al., 2016). We will exclude the 3 reflex items because they make no difference to the overall scores of the test (Gladstone, Danells and Black, 2002; Woodbury et al., 2007; Woytowicz et al., 2017). It is composed of 30 items, each scored on a scale of 0 to 2. It has an excellent overall reliability (Duncan, Propst and Nelson, 1983; Sanford et al., 1993), validity and responsiveness as an indicator of motor impairment severity across different stroke recovery time points (Platz et al., 2005; Hsieh et al., 2009).
Measured: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
Secondary outcomes (3)
Change from Baseline 'Action Research Arm Test (ARAT)' at 4 weeks
is a standardized, observational measure of UE functional capability for adult stroke survivors. It includes 19 items categorized into four subscales (grasp, grip, pinch and gross movement). Task performance on each item is rated on a 4-point ordinal scale, ranging from 0 (no movement) to 3 (movement performed normally) (Yozbatiran, Der-Yeghiaian and Cramer, 2008).
Measured: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
Change from Baseline 'Box and Block Test (BBT)' at 4 weeks
to assess gross manual dexterity. It consists of a wooden box divided by a partition into two equal compartments with 150 wooden blocks placed in one compartment. The participants will be given 60 seconds to move, one by one, as many 2.5 cm blocks as possible from one compartment to the other using only the most affected hand. 15-second trial will be allowed for each participant at the beginning to ensure adequate understanding of the task. BBT has excellent test-retest reliability when tested on more affected (r = 0.98) and less affected hand (r = 0.93) (Chen et al., 2009).
Measured: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
Change from Baseline 'Nine Hole Peg Test (NHPT)' at 4 weeks
is a finger dexterity measure involving timed performance to insert and remove 9 pegs from holes in a wooden board. It showed excellent test retest reliability (Chen et al., 2009), adequate to excellent intra-rater reliability and excellent inter-rater reliability (Heller et al., 1987).
Measured: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start10 Nov 2017
- Primary completion10 Mar 2020
- Study completion14 Mar 2020
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turki Abualait
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Turki Abualait, Imam Abdulrahman Al Faisal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180929
- Sponsor's protocol ID
- IAU
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Effects of Dual-tDCS and Anodal Premotor tDCS Over the Contralesional Hemisphere on the Upper Limb Function and Manual Dexterity in Patients With Chronic Stroke: Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05180929
- Acronym / sponsor ID
- IAU
- Conditions
- Stroke
- Keywords
- tDCS, PMC, IHI, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Turki AbualaitOther government
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 6 Jan 2022 (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: Transcranial direct current stimulation (tDCS) has been gaining increasing interest as a potential therapeutic tool to improve upper extremity (UE) rehabilitation outcomes following stroke. Within the concept of interhemispheric inhibition (IHI), most tDCS studies have applied anodal ipsilesional and/or cathodal contralesional primary motor cortex (M1) tDCS to rebalance IHI and enhance motor recovery. However, compelling evidence suggests that an excitation/inhibition model is oversimplified, and the role of both hemispheres in the encoding of information during motor learning should be acknowledged. Moreover, multiple lines of evidence have demonstrated the potential relevance of contralesional premotor cortex (PMC) for recovery after M1 injury.
Objective: We are aiming to investigate and compare the effects of two tDCS montages at different cortical sites (Dual-M1 vs. a-tDCS over contralesional PMC) by measuring the clinical outcomes of the most affected UE in patients with chronic subcortical stroke.
Methods: 35 participants will be randomly assigned to 1 of 3 groups (Group A received dual- M1 tDCS, Group B received a-tDCS over contralesional PMC, and Group C received sham stimulation). tDCS will be applied using intensity of 2 mA for 20 min. (5 times/week) for 2 consecutive weeks. Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT) will be used to quantify the UE functional motor ability. Box and Block Test (BBT) will be used for gross manual dexterity and Nine Hole Peg Test (NHPT) will be used to measure fine hand dexterity. All measurements will be taken pre-treatment (T0) and post-treatment (T1) immediately after the 10th session, then 4 weeks after the end of stimulation period (T2) to assess the long-term effects.
Expected results: This study would verify whether enhancing the motor cortical hyperexcitability in the contralesional hemisphere has a beneficial on recovery of the paretic hand, or regaining the balance of transcallosal inhibitory circuits between the motor areas in both hemispheres has more positive effects on the motor outcomes . This study would also provide a predictive approach to enable realistic rehabilitation goal-setting by identifying the proper tDCS montage for patients with stroke depending on their impairment level.
Detailed description
This experimental study will be conducted in a sham-controlled, single-blinded randomized controlled design. The subjects will be recruited - by convenience sampling - from the outpatient population of different governmental hospitals in Eastern Province of Saudi Arabia. Neurologists, Physiatrists and Physical therapists will be contacted to recruit potential subjects and IRB-approved letter will be sent to them. The subjects will be screened to determine whether a potential participant is eligible to be enrolled in the study or not. Only the principal investigator (PI) will conduct the screening procedures, which include reviewing medical record, in-person interview and administration of Mini-Mental State Examination. All screening activities will take 15-20 min., and they will be performed in a private screening room. Enrollment will occur after verifying the eligibility and obtaining the signed written consent form. Participants will be enrolled in the study only if they met all the inclusion criteria, which are:
- Male or Female participants aged ≥ 18
- First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (≥ 6 months).
- Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE).
- Mini Mental State Examination Score ≥ 24.
All the participants were receiving conventional physical therapy and occupational therapy sessions (1-2 times/week).
The Exclusion Criteria included the following:
- History of epileptic seizures.
- Pre-stroke motor impairment(s) affecting UE.
- Presence of UE contractures or deformities.
- Botulinum toxin to UE muscles in the last 6 months.
- Presence of damaged skin on the scalp that would interfere with tDCS stimulation.
- Individuals with metallic implant in the brain or medical devices (i.e., cardiac pacemaker, deep brain stimulator, cochlear implants).
- Use of CNS-affecting drugs.
- Additional neurological or psychiatric problem.
- Pregnancy.
After enrollment, all participants will be scheduled to receive 10 sessions over two consecutive weeks (5 sessions/week). Each participant will be seen initially (1st visit) for about 90 min. to conduct all baseline measurements (T0), which will include clinical examinations using different standardized tests for upper limb function, and to conduct the experiment. The follow up sessions (8 sessions) will last for around 30 min. (10 min. for preparation and employing the electrodes + 20 min. for the stimulation). The 10th session will last for about 90 min. to carry out the measurement tests (T1) and to conduct the last stimulation session. The final visit will be scheduled to be 4 weeks after the 10th session to evaluate the long-term effects using the same measurement tests (T2).
All the participants will be blinded to the type of stimulation they received. The PI will take all the baseline measurements (T0), post-stimulation measurements immediately after the 10th session (T1), and long-term effects 4 weeks after the end of the stimulation period (T2). The PI will carry out all tDCS sessions as well.
All the participants will be randomly assigned, using opaque envelopes, to one of three groups:
- Group A (n=11) receive dual-tDCS
- Group B (n=13) receive a-tDCS over PMC in the contralesional hemisphere, and
- Group C (n=11) receive sham stimulation.
This study protocol has been approved by the IRB from the research ethics committee in Imam Abdulrahman Bin Faisal University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual-M1 tDCS | Experimental | Device: Dual M1-tDCSIn the M1- dual tDCS montage, the anodal electrode will be placed above ipsilesional M1 and the cathode will be positioned over contralesional M1. |
| a-tDCS over contralesional PMC | Experimental | Device: a-tDCS over contralesional PMCIn the anodal-tDCS for PMC, the anodal electrode will be placed over the contralesional PMC. The PMC is defined as being 2.5 cm anterior to the M1. The cathodal electrode will be positioned over the contralateral suborbital region |
| Sham tDCS | Sham comparator | Device: Sham tDCSFor sham stimulation, there is no particular electrode configuration to be followed, thus, 6 participants will receive sham stimulation with the configuration will be used in group A, and 5 participants will receive sham stimulation with the configuration will be used in group B. By pressing the sham button, the current will automatically ramped up over 10 sec. till reaching 1 mA, then it will be decreased gradually over 30 seconds till turning off the apparatus. This is to ensure the typical initial itching sensation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (≥ 6 months).
- Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
- Mini Mental State Examination Score ≥ 24
Key exclusion criteria (9 listed)
- History of epileptic seizures.
- Pre-stroke motor impairment(s) affecting UE.
- Presence of UE contractures or deformities.
- Botulinum toxin to UE muscles in the last 6 months.
- Presence of damaged skin on the scalp that would interfere with tDCS stimulation.
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 |
|---|---|---|
| Dual M1-tDCSIn the M1- dual tDCS montage, the anodal electrode will be placed above ipsilesional M1 and the cathode will be positioned over contralesional M1. | Device | Dual-M1 tDCS |
| a-tDCS over contralesional PMCIn the anodal-tDCS for PMC, the anodal electrode will be placed over the contralesional PMC. The PMC is defined as being 2.5 cm anterior to the M1. The cathodal electrode will be positioned over the contralateral suborbital region | Device | a-tDCS over contralesional PMC |
| Sham tDCSFor sham stimulation, there is no particular electrode configuration to be followed, thus, 6 participants will receive sham stimulation with the configuration will be used in group A, and 5 participants will receive sham stimulation with the configuration will be used in group B. By pressing the sham button, the current will automatically ramped up over 10 sec. till reaching 1 mA, then it will be decreased gradually over 30 seconds till turning off the apparatus. This is to ensure the typical initial itching sensation | Device | Sham tDCS |
Primary outcome
Change from Baseline 'Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)' at 4 weeks
Time frame: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
the most frequently used outcome measure when assessing UE function after stroke within the research context (Santisteban et al., 2016). We will exclude the 3 reflex items because they make no difference to the overall scores of the test (Gladstone, Danells and Black, 2002; Woodbury et al., 2007; Woytowicz et al., 2017). It is composed of 30 items, each scored on a scale of 0 to 2. It has an excellent overall reliability (Duncan, Propst and Nelson, 1983; Sanford et al., 1993), validity and responsiveness as an indicator of motor impairment severity across different stroke recovery time points (Platz et al., 2005; Hsieh et al., 2009).
3 secondary outcomes
Change from Baseline 'Action Research Arm Test (ARAT)' at 4 weeks
Time frame: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
Change from Baseline 'Box and Block Test (BBT)' at 4 weeks
Time frame: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
Change from Baseline 'Nine Hole Peg Test (NHPT)' at 4 weeks
Time frame: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
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 6 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual M1-tDCS and a-tDCS over contralesional PMC in people with Stroke, run by Turki Abualait 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 3 inclusion and 9 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 6 Jan 2022. 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?
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?
Change from Baseline 'Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)' at 4 weeks (time frame: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects). 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 6 Jan 2022.