StrokeNCT06525129
Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation (tDCS) vs Anodal Cerebral tDCS
A study testing Cerebellar stimulation group (CbSG) and Cerebral (M1) Stimulation group (MSG) in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To investigate which one of the two cerebellar and cerebral stimulation in comparison to sham stimulation is more effective in enhancing balance and postural stability in stroke patients Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Cerebellar stimulation group (CbSG) and Cerebral (M1) Stimulation group (MSG)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2024to 1 Feb 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The study focused on individuals who had their first stroke,
- Additionally, participants needed to have a score of 6 or higher on the Johns Hopkins Fall Risk Assessment Tool (JHFRAT).
- The inclusion criteria mandated that participants must have the ability to give written consent, walk without any help, and
- have a functional condition that allows them to actively participate in the Biodex balancing training program.
Who cannot join
- Individuals with concurrent neurological problems such as Alzheimer's, Parkinson's, or cerebellar abnormalities,
- as well as those with psychological ailments, were excluded during the initial assessment phase.
- In addition, individuals who scored below 20 on the Mini Mental Status Examination Test (MMSE),
- displayed motor disorders that affected their ability to walk or use their lower limbs,
- were currently taking sedative medications, had amnesia, depression, radiculopathy, lumbar spinal cord root involvement, auditory or visual impairments, vertigo, recent fractures, severe cardiac problems,
- or had undergone electrotherapy that affected their nervous system within the past two weeks were also not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation vs Anodal Cerebral Transcranial Direct Current Stimulation on Balance, Its Components and Postural Stability in Stroke Patients
To investigate which one of the two cerebellar and cerebral stimulation in comparison to sham stimulation is more effective in enhancing balance and postural stability in stroke patients
- Conditions
- Stroke
- Being tested
- Cerebellar stimulation group (CbSG), Cerebral (M1) Stimulation group (MSG), Sham Stimulation group (SSG)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebellar stimulation group (CbSG)Other
Anodal transcranial direct current stimulation was given using a portable battery-driven brain stimulator (The Brain Stimulator v3.0 Deluxe tDCS Kit, using Professional 3x3 inches Amrex Sponge Electrodes). Skin was prepared before application of electrodes by cleaning the skin surface using alcohol swabs. In cerebellar stimulation group (CbSG) a stimulation intensity of 2mA for duration of 20 minutes. In order to avoid sudden initiation and termination of the stimulation the first and last 10 seconds of anodal tDCS application, current will gradually fade in/fade out to avoid any sudden starting or stopping of the stimulation. For the CbSG active anodal electrode was placed over the cerebellum with about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode was placed on right buccinator muscle.
Cerebral (M1) Stimulation group (MSG)Other
In the M1 Stimulation Group (MSG) a similar intensity of current with 2mA was applied for a period of 20 minutes. Skin was cleaned with alcohol swab ahead of placing the electrodes. The anode was positioned over the lesioned M1 motor cortex area (C3, International 10-20 system) while the cathode was placed over the contra-lateral supraorbital area. Due to the large size of electrodes, the active electrode covered the area of M1 for the hand, arm, trunk, and the LL. Ten sessions of anodal tDCS were applied over a duration of 2 weeks. The stimulation was applied during active participation of patients in Biodex balance training.
Sham Stimulation group (SSG)Other
In Sham Stimulation group (SSG) Ten sessions of anodal tDCS were applied over a duration of 2 weeks having same intensity i.e., 2 mA stimulation was used for a period of 30 seconds and then gradually ramped-down and turned off for the rest of the treatment time of 20 minutes. The same procedure for skin preparation was used as in the other two groups. Electrode placement for SSG was same as in MSG for half of the patients i.e. 8 participants; anode will be placed over the left (dominant) lesioned M1 whereas the cathode will be positioned over the right (contralateral) supraorbital area. For the other 8 participants the stimulation montages were similar to cerebellar stimulation group. The active anodal electrode was placed over the cerebellum with about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode was placed on right Buccinator Muscle.
| Study group | Role | What they receive |
|---|---|---|
| Cerebellar stimulation group (CbSG) | Experimental | Not described Receives: Other: Cerebellar stimulation group (CbSG) |
| Cerebral (M1) Stimulation group (MSG) | Experimental | Not described Receives: Other: Cerebral (M1) Stimulation group (MSG) |
| Sham Stimulation group (SSG) | Other | Not described Receives: Other: Sham Stimulation group (SSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex balance system
The biodex balance system based specific dynamic postural tests were delineated for implementation on both static and dynamic levels. Postural stability tests were performed at three levels of stability: 12 (maximum stability = static), 7 (moderate stability) and 3 (slight stability).
Measured: 2 weeks
Berg balance scale
The Berg balance scale (BBS) is used to assess the participant's ability to retain stability.
The BBS is a widely used test for the assessment of the elderly population with impairment of balance and individuals with neurological disorders while sitting, standing, and transferring. This test included both static and dynamic type tasks. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points. The scale has been shown to be reliable and valid in stroke patients. A cut-off score of 45 points is used for fall prediction. The BBS involves 14 tasks: a total score of 56. Equipment required for this test was a stopwatch or watch with a second hand and a ruler or other indicator of 2, 5, and 10 inches.
Measured: 2 weeks
Timed up and go test
The Timed Up and Go (TUG) test was designed for the evaluation of balance and Measures mobility in people who are able to walk on their own (assistive device permitted) to find out the risk of fall. The subjects will be required to stand up from a chair, walk 3 m, turn around, return to the chair, and sit down. The time taken to complete this task will be measured. The test will be informed three times. The time required to complete this task will be measured from a stopwatch. The average values from 3 trials, with 1-min rest between each trial, were used for data analysis.
Measured: 2 weeks
Bestest balance evaluation system
Changes from the base line, immediately after Intervention and then again after 1 hour.
Balance Evaluation Systems Test (BESTest) is a 36-item assessment of balance impairments across 6 postural control contexts. Total score of 108 points total, calculated into a percentage score (0-100%). Also, total sub-scores exist for each above listed system. Item- level scores range from 0 (severe impairment) to 3 (no impairment)
Measured: 2 weeks
TDCSs adverse effects questionnaire
Transcranial Direct-Current Stimulation (tDCS) adverse effects questionnaire:
Do you experience any of the following symptoms or side- effects? Headache, Neck pain, Scalp pain, Tingling, Itching, burning sensation, Skin redness, Sleepiness, Trouble concentrating, Acute mood change, Others (specify) for each symptom patient can give value (1-4) (1, absent; 2, mild; 3, moderate; 4, severe). If present: Is this related to tDCS?
(1, none; 2, remote; 3, possible; 4, probable; 5, definite)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, PhD*, Study chair, Riphah International UniversityQurat Ul Ain, PhD*, Principal investigator, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525129
- Sponsor's protocol ID
- Qurat ul Ain3
- Status last verified
- Mar 2025
- First submitted
- 24 Jul 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation vs Anodal Cerebral Transcranial Direct Current Stimulation on Balance, Its Components and Postural Stability in Stroke Patients
- ClinicalTrials.gov ID
- NCT06525129
- Acronym / sponsor ID
- Qurat ul Ain3
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 29 Jul 2024 (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.
To investigate which one of the two cerebellar and cerebral stimulation in comparison to sham stimulation is more effective in enhancing balance and postural stability in stroke patients
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cerebellar stimulation group (CbSG) | Experimental | Other: Cerebellar stimulation group (CbSG) |
| Cerebral (M1) Stimulation group (MSG) | Experimental | Other: Cerebral (M1) Stimulation group (MSG) |
| Sham Stimulation group (SSG) | Other | Other: Sham Stimulation group (SSG) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The study focused on individuals who had their first stroke,
- Additionally, participants needed to have a score of 6 or higher on the Johns Hopkins Fall Risk Assessment Tool (JHFRAT).
- The inclusion criteria mandated that participants must have the ability to give written consent, walk without any help, and
- have a functional condition that allows them to actively participate in the Biodex balancing training program.
Key exclusion criteria (6 listed)
- Individuals with concurrent neurological problems such as Alzheimer's, Parkinson's, or cerebellar abnormalities,
- as well as those with psychological ailments, were excluded during the initial assessment phase.
- In addition, individuals who scored below 20 on the Mini Mental Status Examination Test (MMSE),
- displayed motor disorders that affected their ability to walk or use their lower limbs,
- were currently taking sedative medications, had amnesia, depression, radiculopathy, lumbar spinal cord root involvement, auditory or visual impairments, vertigo, recent fractures, severe cardiac problems,
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 |
|---|---|---|
| Cerebellar stimulation group (CbSG)Anodal transcranial direct current stimulation was given using a portable battery-driven brain stimulator (The Brain Stimulator v3.0 Deluxe tDCS Kit, using Professional 3x3 inches Amrex Sponge Electrodes). Skin was prepared before application of electrodes by cleaning the skin surface using alcohol swabs. In cerebellar stimulation group (CbSG) a stimulation intensity of 2mA for duration of 20 minutes. In order to avoid sudden initiation and termination of the stimulation the first and last 10 seconds of anodal tDCS application, current will gradually fade in/fade out to avoid any sudden starting or stopping of the stimulation. For the CbSG active anodal electrode was placed over the cerebellum with about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode was placed on right buccinator muscle. | Other | Cerebellar stimulation group (CbSG) |
| Cerebral (M1) Stimulation group (MSG)In the M1 Stimulation Group (MSG) a similar intensity of current with 2mA was applied for a period of 20 minutes. Skin was cleaned with alcohol swab ahead of placing the electrodes. The anode was positioned over the lesioned M1 motor cortex area (C3, International 10-20 system) while the cathode was placed over the contra-lateral supraorbital area. Due to the large size of electrodes, the active electrode covered the area of M1 for the hand, arm, trunk, and the LL. Ten sessions of anodal tDCS were applied over a duration of 2 weeks. The stimulation was applied during active participation of patients in Biodex balance training. | Other | Cerebral (M1) Stimulation group (MSG) |
| Sham Stimulation group (SSG)In Sham Stimulation group (SSG) Ten sessions of anodal tDCS were applied over a duration of 2 weeks having same intensity i.e., 2 mA stimulation was used for a period of 30 seconds and then gradually ramped-down and turned off for the rest of the treatment time of 20 minutes. The same procedure for skin preparation was used as in the other two groups. Electrode placement for SSG was same as in MSG for half of the patients i.e. 8 participants; anode will be placed over the left (dominant) lesioned M1 whereas the cathode will be positioned over the right (contralateral) supraorbital area. For the other 8 participants the stimulation montages were similar to cerebellar stimulation group. The active anodal electrode was placed over the cerebellum with about 1-2 cm below inion occipital protuberance, whereas the returning cathodal electrode was placed on right Buccinator Muscle. | Other | Sham Stimulation group (SSG) |
Primary outcome
Biodex balance system
Time frame: 2 weeks
The biodex balance system based specific dynamic postural tests were delineated for implementation on both static and dynamic levels. Postural stability tests were performed at three levels of stability: 12 (maximum stability = static), 7 (moderate stability) and 3 (slight stability).
Berg balance scale
Time frame: 2 weeks
The Berg balance scale (BBS) is used to assess the participant's ability to retain stability. The BBS is a widely used test for the assessment of the elderly population with impairment of balance and individuals with neurological disorders while sitting, standing, and transferring. This test included both static and dynamic type tasks. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points. The scale has been shown to be reliable and valid in stroke patients. A cut-off score of 45 points is used for fall prediction. The BBS involves 14 tasks: a total score of 56. Equipment required for this test was a stopwatch or watch with a second hand and a ruler or other indicator of 2, 5, and 10 inches.
Timed up and go test
Time frame: 2 weeks
The Timed Up and Go (TUG) test was designed for the evaluation of balance and Measures mobility in people who are able to walk on their own (assistive device permitted) to find out the risk of fall. The subjects will be required to stand up from a chair, walk 3 m, turn around, return to the chair, and sit down. The time taken to complete this task will be measured. The test will be informed three times. The time required to complete this task will be measured from a stopwatch. The average values from 3 trials, with 1-min rest between each trial, were used for data analysis.
Bestest balance evaluation system
Time frame: 2 weeks
Changes from the base line, immediately after Intervention and then again after 1 hour. Balance Evaluation Systems Test (BESTest) is a 36-item assessment of balance impairments across 6 postural control contexts. Total score of 108 points total, calculated into a percentage score (0-100%). Also, total sub-scores exist for each above listed system. Item- level scores range from 0 (severe impairment) to 3 (no impairment)
TDCSs adverse effects questionnaire
Time frame: 2 weeks
Transcranial Direct-Current Stimulation (tDCS) adverse effects questionnaire: Do you experience any of the following symptoms or side- effects? Headache, Neck pain, Scalp pain, Tingling, Itching, burning sensation, Skin redness, Sleepiness, Trouble concentrating, Acute mood change, Others (specify) for each symptom patient can give value (1-4) (1, absent; 2, mild; 3, moderate; 4, severe). If present: Is this related to tDCS? (1, none; 2, remote; 3, possible; 4, probable; 5, definite)
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 20 Mar 2025.
- 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.
Muhammad Iqbal Tariq, PhD* study chair
Riphah International University
Qurat Ul Ain, PhD* principal investigator
Xi'an Jiaotong 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 Cerebellar stimulation group (CbSG) and Cerebral (M1) Stimulation group (MSG) in people with Stroke, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 6 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 20 Mar 2025. 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 Pakistan. 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. 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?
Biodex balance system (time frame: 2 weeks). The study lists 5 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 20 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.