StrokeNCT05903599
Anodal TDCS and Postural Stability in Subacute Stroke
A study testing Anodal transcranial direct current stimulation in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke patients experience weakening of muscles on the affected side. Damage to the motor cortex and the pyramidal tract due to a stroke leads to a motor control disorders and co-contraction of trunk muscles due to abnormal levels of abdominal muscle tension and voluntary movement. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Anodal transcranial direct current stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2023to 31 Jan 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ischemic stroke
- Sub-acute stroke
- Minimum score of 18 on PASS
Who cannot join
- Hearing and Visual loss/ deficit
- Recurrent CVA
- Neurological condition affects the cognition
- Wound at skull
- Presence of shunt and/or metallic implant at cranial region
- Brain tumors
- Musculoskeletal conditions/ surgery in the lower extremities
- Cognitively compromised
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Anodal Transcranial Direct Current Stimulation on Postural Stability in Sub-Acute Stroke
Stroke patients experience weakening of muscles on the affected side. Damage to the motor cortex and the pyramidal tract due to a stroke leads to a motor control disorders and co-contraction of trunk muscles due to abnormal levels of abdominal muscle tension and voluntary movement.
Read the detailed description
TDCS is known to modulate motor excitability in humans and motor performance is crucial in postural control. Studies reports that applying anodal TDCS to the ipsilesional motor cortex improved motor functioning in which the Transcranial Direct Current Stimulation may have stimulated preserved areas of the motor cortex to enhance synaptic efficiency along the corticospinal tract.
Anodal TDCS has been shown to have immediate and short-term effects in stroke but its long-term effects in stroke are still unclear. Additionally, the available literature focuses on acute and chronic stages of stroke so we will target subacute stage of stroke. Therefore, this study is designed to investigate the short and long-term effects of Anodal Transcranial Direct Current Stimulation on postural stability in subacute stroke.
- Conditions
- Stroke
- Being tested
- Anodal transcranial direct current stimulation, Sham Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial direct current stimulationOther
The size of both electrodes will be 5cm x 5cm placed on the head with the anode on the primary motor cortex M1 of the affected side while the cathode on the contralesional eye. The duration of the stimulation of anodal TDCS is 20 min and the intensity of current will be 2mA. The ramp up and down period will be 30se each. Treatment duration will be 5 times a week for 6 weeks for postural stability.
Sham StimulationOther
postural training by visual feedback and weight shifting towards the non-paretic side. This program will have two phases. Phase one have 4 stages; The first stage (sessions 1-7), second stage (sessions 8-14), third stage (sessions 15-22), fourth stage (sessions 23-30).
Next phase will include the exercises including balancing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | anodal Transcranial direct current stimulation with saline soaked sponges will be used on electrodes, for 20 mins in addition to the 60 mins of conventional treatment. Receives: Other: Anodal transcranial direct current stimulation |
| Group B | Sham comparator | A sham stimulation will be given. It will be comprised 20 min of sham TDCS followed by 60 mins of conventional treatment for postural stability in sub-acute stroke Receives: Other: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Assessment Scale for Stroke Patients (PASS)
PASS evaluates the postural imbalance and functional abilities of patients with stroke in several conditions (lying on back, sitting, standing and while changing positions). This scale is composed of 12 items. Score can vary from 0 to 3, with 0 being the lowest level of functionality and 3 the highest; the total score be 36.
Measured: 12th week
Trunk impairment scale (TIS) for Stroke Patients
It evaluates motor impairment of the trunk after stroke. The TIS scores, on a range from 0 to 23, static and dynamic sitting trunkal stability as well as trunk coordination. It also score the quality of trunk movement and to be a guide for treatment. Number of items are 7, score of each item is 0-3.
Measured: 12th week
Secondary outcomes (3)
Timed Up and Go Test (TUG)
TUG test is a general performance test used to assess mobility, balance and locomotor performance in patients with balance disturbances. The patients are asked to stand up from chair, walk to a line of 3 meters length at a normal pace, turn and walk back to the chair at your normal pace and sit down. A patient whose score is less than 10 seconds is characterized as completely independent. Assessment time will be at 0, 3rd, 6th,9th,12th week
Measured: 12th week
Functional Reach Test (FRT)
a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. The patient is instructed to stand next to but not touching a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist. The assessor records the starting position at the third metacarpal head on the yardstick. Instruct the patient to reach as far as you can forward without taking a step. The location of the third metacarpal is recorded. Scores are determined by assessing the difference between the start and end positions in the reach distance usually measured in inches. Three trials should be done and the average of the last two is noted. Assessment time will be at 0, 3rd, 6th,9th,12th week
Measured: 12th week
Stroke Specific Quality of life Scale (SS-QoL)
a reliable and valid tool for measuring self-reported health -related quality of life. It is a patient centered outcome measure intended to provide an assessment of health-related quality of life specific with stroke. Scale domains and items were derived from series of interviews with post stroke patients. They must respond to each question of the SS-QOL with reference to the past week. It contains 49 items in 12 domains: mobility, energy, upper extremity function (5 items), work/productivity (3 items ), mood (5 items), social roles (5 items),family roles (3 items ), language (5 items ), thinking (3 items), personality (3 items) higher scores indicate better functioning. Assessment time will be at 0, 3rd, 6th,9th,12th week
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start2 May 2023
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903599
- Sponsor's protocol ID
- REC01353 Somia Shakeb
- Status last verified
- Apr 2024
- First submitted
- 6 Jun 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saeys W, Vereeck L, Lafosse C, Truijen S, Wuyts FL, Van De Heyning P. Transcranial direct current stimulation in the recovery of postural control after stroke: a pilot study. Disabil Rehabil. 2015;37(20):1857-63. doi: 10.3109/09638288.2014.982834. Epub 2015 Jul 9.
PubMed 25401406Halmi Z, Stone TW, Dinya E, Mally J. Postural instability years after stroke. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105038. doi: 10.1016/j.jstrokecerebrovasdis.2020.105038. Epub 2020 Jun 23.
PubMed 32807450Bornheim S, Croisier JL, Maquet P, Kaux JF. Transcranial direct current stimulation associated with physical-therapy in acute stroke patients - A randomized, triple blind, sham-controlled study. Brain Stimul. 2020 Mar-Apr;13(2):329-336. doi: 10.1016/j.brs.2019.10.019. Epub 2019 Oct 31.
PubMed 31735645
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anodal Transcranial Direct Current Stimulation on Postural Stability in Sub-Acute Stroke
- ClinicalTrials.gov ID
- NCT05903599
- Acronym / sponsor ID
- REC01353 Somia Shakeb
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 15 Jun 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.
Stroke patients experience weakening of muscles on the affected side. Damage to the motor cortex and the pyramidal tract due to a stroke leads to a motor control disorders and co-contraction of trunk muscles due to abnormal levels of abdominal muscle tension and voluntary movement.
Detailed description
TDCS is known to modulate motor excitability in humans and motor performance is crucial in postural control. Studies reports that applying anodal TDCS to the ipsilesional motor cortex improved motor functioning in which the Transcranial Direct Current Stimulation may have stimulated preserved areas of the motor cortex to enhance synaptic efficiency along the corticospinal tract.
Anodal TDCS has been shown to have immediate and short-term effects in stroke but its long-term effects in stroke are still unclear. Additionally, the available literature focuses on acute and chronic stages of stroke so we will target subacute stage of stroke. Therefore, this study is designed to investigate the short and long-term effects of Anodal Transcranial Direct Current Stimulation on postural stability in subacute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Anodal transcranial direct current stimulationanodal Transcranial direct current stimulation with saline soaked sponges will be used on electrodes, for 20 mins in addition to the 60 mins of conventional treatment. |
| Group B | Sham comparator | Other: Sham StimulationA sham stimulation will be given. It will be comprised 20 min of sham TDCS followed by 60 mins of conventional treatment for postural stability in sub-acute stroke |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ischemic stroke
- Sub-acute stroke
- Minimum score of 18 on PASS
Key exclusion criteria (8 listed)
- Hearing and Visual loss/ deficit
- Recurrent CVA
- Neurological condition affects the cognition
- Wound at skull
- Presence of shunt and/or metallic implant at cranial region
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 stimulationThe size of both electrodes will be 5cm x 5cm placed on the head with the anode on the primary motor cortex M1 of the affected side while the cathode on the contralesional eye. The duration of the stimulation of anodal TDCS is 20 min and the intensity of current will be 2mA. The ramp up and down period will be 30se each. Treatment duration will be 5 times a week for 6 weeks for postural stability. | Other | Group A |
| Sham Stimulationpostural training by visual feedback and weight shifting towards the non-paretic side. This program will have two phases. Phase one have 4 stages; The first stage (sessions 1-7), second stage (sessions 8-14), third stage (sessions 15-22), fourth stage (sessions 23-30). Next phase will include the exercises including balancing exercises. | Other | Group B |
Primary outcome
Postural Assessment Scale for Stroke Patients (PASS)
Time frame: 12th week
PASS evaluates the postural imbalance and functional abilities of patients with stroke in several conditions (lying on back, sitting, standing and while changing positions). This scale is composed of 12 items. Score can vary from 0 to 3, with 0 being the lowest level of functionality and 3 the highest; the total score be 36.
Trunk impairment scale (TIS) for Stroke Patients
Time frame: 12th week
It evaluates motor impairment of the trunk after stroke. The TIS scores, on a range from 0 to 23, static and dynamic sitting trunkal stability as well as trunk coordination. It also score the quality of trunk movement and to be a guide for treatment. Number of items are 7, score of each item is 0-3.
3 secondary outcomes
Timed Up and Go Test (TUG)
Time frame: 12th week
Functional Reach Test (FRT)
Time frame: 12th week
Stroke Specific Quality of life Scale (SS-QoL)
Time frame: 12th week
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 19 Apr 2024.
- Background: PubMed 25401406Saeys W, Vereeck L, Lafosse C, Truijen S, Wuyts FL, Van De Heyning P. Transcranial direct current stimulation in the recovery of postural control after stroke: a pilot study. Disabil Rehabil. 2015;37(20):1857-63. doi: 10.3109/09638288.2014.982834. Epub 2015 Jul 9.
- Background: PubMed 32807450Halmi Z, Stone TW, Dinya E, Mally J. Postural instability years after stroke. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105038. doi: 10.1016/j.jstrokecerebrovasdis.2020.105038. Epub 2020 Jun 23.
- Background: PubMed 31735645Bornheim S, Croisier JL, Maquet P, Kaux JF. Transcranial direct current stimulation associated with physical-therapy in acute stroke patients - A randomized, triple blind, sham-controlled study. Brain Stimul. 2020 Mar-Apr;13(2):329-336. doi: 10.1016/j.brs.2019.10.019. Epub 2019 Oct 31.
- 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.
Mirza Obaid Baig, MSPT 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 transcranial direct current stimulation 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 3 inclusion and 8 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 19 Apr 2024. 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?
Postural Assessment Scale for Stroke Patients (PASS) (time frame: 12th week). The study lists 2 primary outcomes in all. 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 NCT05903599, which also lists 3 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 19 Apr 2024.