StrokeNCT05129683
Single Session of Anodal Cerebellar vs Cerebral Transcranial Direct Current Stimulation in Stroke Patients
A study testing Anodal tDCS cerebellar stimulation group and Anodal tDCS cerebral (M1) stimulation group in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effect of anodal cerebellar transcranial direct current stimulation (ctDCS) vs anodal cerebral direct current stimulation on balance, mobility and cognition in stroke patients in stroke patients Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Anodal tDCS cerebellar stimulation group and Anodal tDCS cerebral (M1) stimulation group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Oct 2021to 30 Sep 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability to give written consent.
- Able to walk unassisted
- Functional status allowing the participants to participate in the balance training.
- Score 6 or above on Johns Hopkins fall risk assessment tool
Who cannot join
- Neurological diseases, such as Parkinson, Alzheimer
- Any history of psychological illnesses
- Receipt of electrotherapy that might affect the nervous system in the two weeks prior to the study
- Cerebellar disorders
- use of any sedative medicines in the two days prior to the study
- any symptoms of amnesia and depression;
Show all 15Show fewer
- Memory disorders with scores below 21 on the Mini Mental Status Examination test
- Any signs of severe motor disorders in the lower extremity which cause any movement limitation or deformity
- Any signs of radiculopathy or root lumbar spinal cord involvement
- Any visual or auditory impairment, or vertigo reports
- Use of a heart rate regulator
- Any structural deformities in the lower extremities or the spine
- Any abnormalities in the vestibular system
- History of recent fracture
- Inability to move without assistance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Single Session of Anodal Cerebellar Transcranial Direct Current Stimulation vs Anodal Cerebral Transcranial Direct Current Stimulation on Balance, Mobility and Cognition in Stroke Patients
To compare the effect of anodal cerebellar transcranial direct current stimulation (ctDCS) vs anodal cerebral direct current stimulation on balance, mobility and cognition in stroke patients in stroke patients
- Conditions
- Stroke
- Being tested
- Anodal tDCS cerebellar stimulation group, Anodal tDCS cerebral (M1) stimulation group, sham group
- Keywords
- Transcranial Direct Current Stimulation, Anodal Cerebral
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCS cerebellar stimulation groupOther
Single-session atDCS (2 mA, 20 min). The active (anode) and the returning (cathode) electrodes will be placed bilaterally over the cerebellum (1 -2 cm below inion of occipital bone) and the right buccinator muscle, respectively Xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins will also be given
Anodal tDCS cerebral (M1) stimulation groupOther
single session a-tDCS (2 mA, 20 min), the anode will be positioned over the lesioned M1 (C3, International 10-20 system) and the cathode would be located over the supraorbital area. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.
sham groupOther
single session a-tDCS (2 mA, 20 min), Sham tDCS followed a similar protocol as Anodal tDCS cerebral (M1) stimulation and arrangement but stimulation for 30 s, after which the current was ramped-down and turned off for the rest of the treatment. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS cerebellar stimulation group: | Experimental | Anodal tDCS cerebellar stimulation Receives: Other: Anodal tDCS cerebellar stimulation group |
| Anodal tDCS cerebral (M1) stimulation group: | Experimental | Anodal tDCS cerebral (M1) stimulation Receives: Other: Anodal tDCS cerebral (M1) stimulation group |
| Sham Group | Sham comparator | Sham: Single-session a-tDCS (2 mA, 20 min), Receives: Other: sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from the base line, Berg balance scale
Changes from the base line, Immediately after Intervention and then again after 1 hour. 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 elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. 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 were a stop watch or watch with a second's hand and a ruler or other indicator of 2, 5, and 10 inches.
Measured: Immediately after Intervention and then again after 1 hour.
Timed Up and Go test
Changes from the base line, Immediately after Intervention and then again after 1 hour. 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: Immediately after Intervention and then again after 1 hour.
Balance Evaluation Systems Test
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 in to 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: Immediately after Intervention and then again after 1 hour.
Secondary outcomes (6)
Montreal cognitive Scale
Changes from the base line, Immediately after Intervention and then again after 1 hour. The tool used for cognitive impairment is Montreal Cognitive Assessment (MoCA). As there is not at all, fairly effective measuring tool for the early diagnosis of cognitive impairments. MoCA is a successful screening test used for the screening of mild cognitive impairment. Scores of MoCA ranges from 0-30.Interpretation of MoCA indicates that score of 26 and above normal, 18 -25 score indicates low cognitive impairments, 10 -18 score considered normal or moderate cognitive impairment while greater than 10 is considered to be severe cognitive impairments.
Measured: 1 hour
tDCS Adverse Effects Questionnaire :
Changes from the base line, Immediately after Intervention and then again after 1 hour.. Transcranial Direct-Current Stimulation (tDCS) adverse effects questionaire:
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: Immediately after Intervention and then again after 1 hour.
6 min walk test: Distance (meters)
Changes from the base line, Immediately after Intervention and then again after 1 hour. 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
Measured: Immediately after Intervention and then again after 1 hour.
Timed 25-Foot Walk test
Changes from the base line, Immediately after Intervention and then again after 1 hour. Timed 25-Foot Walk (T25-FW) test is a quantitative mobility and leg function performance test based on a timed 25-walk. Two trials will be given to the patient and time will be noted in seconds
Measured: Immediately after Intervention and then again after 1 hour.
Johns Hopkins fall risk assessment Tool
Changes from the base line, Immediately after Intervention and then again after 1 hour. Risk of falling was assessed using the Johns Hopkins Fall Risk Assessment score 13,14 ; a score of less than 6 is considered low risk, 6 to 13 is considered moderate risk, and greater than 13 is considered high risk.
Measured: Immediately after Intervention and then again after 1 hour.
Mini mental state examination (MMSE)
Changes from the base line, Immediately after Intervention and then again after 1 hour. Mini mental state examination (MMSE): used to screen for cognitive impairment in elderly. The maximum MMSE score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.
Measured: Immediately after Intervention and then again after 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start5 Oct 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
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.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arshad Nawaz Malik, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129683
- Sponsor's protocol ID
- REC/01141 Qurat Study1
- Status last verified
- Aug 2023
- First submitted
- 23 Sep 2021
- Last updated
- 3 Aug 2023
- 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 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Session of Anodal Cerebellar Transcranial Direct Current Stimulation vs Anodal Cerebral Transcranial Direct Current Stimulation on Balance, Mobility and Cognition in Stroke Patients
- ClinicalTrials.gov ID
- NCT05129683
- Acronym / sponsor ID
- REC/01141 Qurat Study1
- Conditions
- Stroke
- Keywords
- Transcranial Direct Current Stimulation, Anodal Cerebral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effect of anodal cerebellar transcranial direct current stimulation (ctDCS) vs anodal cerebral direct current stimulation on balance, mobility and cognition in stroke patients in stroke patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS cerebellar stimulation group: | Experimental | Other: Anodal tDCS cerebellar stimulation groupAnodal tDCS cerebellar stimulation |
| Anodal tDCS cerebral (M1) stimulation group: | Experimental | Other: Anodal tDCS cerebral (M1) stimulation groupAnodal tDCS cerebral (M1) stimulation |
| Sham Group | Sham comparator | Other: sham groupSham: Single-session a-tDCS (2 mA, 20 min), |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ability to give written consent.
- Able to walk unassisted
- Functional status allowing the participants to participate in the balance training.
- Score 6 or above on Johns Hopkins fall risk assessment tool
Key exclusion criteria (15 listed)
- Neurological diseases, such as Parkinson, Alzheimer
- Any history of psychological illnesses
- Receipt of electrotherapy that might affect the nervous system in the two weeks prior to the study
- Cerebellar disorders
- use of any sedative medicines in the two days prior to the study
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 tDCS cerebellar stimulation groupSingle-session atDCS (2 mA, 20 min). The active (anode) and the returning (cathode) electrodes will be placed bilaterally over the cerebellum (1 -2 cm below inion of occipital bone) and the right buccinator muscle, respectively Xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins will also be given | Other | Anodal tDCS cerebellar stimulation group: |
| Anodal tDCS cerebral (M1) stimulation groupsingle session a-tDCS (2 mA, 20 min), the anode will be positioned over the lesioned M1 (C3, International 10-20 system) and the cathode would be located over the supraorbital area. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins. | Other | Anodal tDCS cerebral (M1) stimulation group: |
| sham groupsingle session a-tDCS (2 mA, 20 min), Sham tDCS followed a similar protocol as Anodal tDCS cerebral (M1) stimulation and arrangement but stimulation for 30 s, after which the current was ramped-down and turned off for the rest of the treatment. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins. | Other | Sham Group |
Primary outcome
Changes from the base line, Berg balance scale
Time frame: Immediately after Intervention and then again after 1 hour.
Changes from the base line, Immediately after Intervention and then again after 1 hour. 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 elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. 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 were a stop watch or watch with a second's hand and a ruler or other indicator of 2, 5, and 10 inches.
Timed Up and Go test
Time frame: Immediately after Intervention and then again after 1 hour.
Changes from the base line, Immediately after Intervention and then again after 1 hour. 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.
Balance Evaluation Systems Test
Time frame: Immediately after Intervention and then again after 1 hour.
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 in to 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)
6 secondary outcomes
Montreal cognitive Scale
Time frame: 1 hour
tDCS Adverse Effects Questionnaire :
Time frame: Immediately after Intervention and then again after 1 hour.
6 min walk test: Distance (meters)
Time frame: Immediately after Intervention and then again after 1 hour.
Timed 25-Foot Walk test
Time frame: Immediately after Intervention and then again after 1 hour.
Johns Hopkins fall risk assessment Tool
Time frame: Immediately after Intervention and then again after 1 hour.
Mini mental state examination (MMSE)
Time frame: Immediately after Intervention and then again after 1 hour.
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 3 Aug 2023.
- 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.
Arshad Nawaz Malik, PhD principal investigator
Riphah International 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 tDCS cerebellar stimulation group and Anodal tDCS cerebral (M1) stimulation group 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 15 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 3 Aug 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 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. 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?
Changes from the base line, Berg balance scale (time frame: Immediately after Intervention and then again after 1 hour.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.