Effects of tES Combined With CMDT Gait Training on Cognition, Cortical Activity, Spinal Motoneuron Excitability and Motor Performance in Stroke Individuals
NCT ID: NCT07236216
Last Updated: 2025-11-19
Study Results
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Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-20
2027-12-30
Brief Summary
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Detailed Description
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Follwoing stroke, an alterations of cortical activity between ipsileasional hemisphere and contralesion hemisphere affect the spinal lelvel as it leads to increase spinal motoneuron excitability. An increase of spinal motoneuron excitability is likely due to abnormal control from cortex to spinal cord via descending pathway. Furthermore, hyperexcitability of spinal motoneuron is associated with post-stroke spasticity. However, the excat mechanisms of spasticity in post stroke remians unclear. Potential causes include imbalance in descending pathway regulation, abnormal intraspinal processing, and altered muscular viscoelasticity. Changes in spinal motoneuron excitability can be assessed using Hoffmann's reflex (H-reflex).
Motor imapirments following stroke affects activities of daily living (ADLs), moreover cognitive impairements is commonly obsrved in post-stroke individuals that may limits motor and functional recovery and limits effectiveness of rehabilitation. These impairments affect both single- and duals-task activities, especially walking performance and increasing risk of falls in stroke individuals. In recent years, combining bottom-up and top-down approaches has been greater potential in promoting neural plasticity and enhancing motor recovery compared to single approach. Bottom-up approaches refers to rehabilitation that act on physical level and expected chnages in nervous system level, while top-down approach induce change in cortical level to induce change in motor function or physical level. The non-invasive brain stimulation (NIBS) is a top-down approach that enhance neural plasticity and mediated motor-relearning in neurological conditions. Transcranial electrical stimulation (tES) is one of NIBS which the most coom tES techniques are transcranial direct current stimulation (tDCS) and transcranial alternating currnt stimulation (tACS). Both tDCS and tACS are different in their wave forms. tDCS delivers a weak direct current with polartiy-specific effects, while tACS enhance neural plasticity and endogenous brain wave with frequency-specific. A recent review demonstrated the effectiveness of tDCS in improvement of motor function, functional abilities and cognitive function. Furthermore, a previous study demonstrated an improvement in cognitive function and ADLs following combining 2mA of tDCS with CMDT training. However, the amount of evidence on the effects of tACS is much less than that for tDCS, as it has only recently started to gain interest. The frequency used in tACS study mainly follows the association of brain wave and function. A previous review showed that gamma tACS enhance cognitive performance, working memory and logical thinking. In healthy population, a previous study demonstrated that applied gamma-tACS over M1 significantly improved velocity and acceleration of visuomotor task; nevertheless, this improvement did not found in beta-tACS. To provide evidence of the effects of tACS in the stroke population and to identify which type of transcranial electrical stimulation is most appropriate for stroke rehabilitation, a comparison between tDCS and tACS is necessary. Both tES technique will be combined with conventional physical therapy for 12 sessions (3 days/week for 4 weeks). tES will be provided for 20 minutes, then followed by convention physical therapy (1-hour) and cognitive-motor dual-task gait training (30-minute). Cortical activity will be assessed by EEG and fNIRS. Absoule spectral power of each frequency bands (alpha, beta, delta, and theta) will be analyze. The hemodynamics data will be analyze to represent changes of blood flow to the brain after intervention. The Hmax/Mmax ratio from flexor carpi radialis and soleus will be recorded to represent changes in spinal motoneuron excitability. The Fugl-Meyer assessment of upper and lower extremity and Timed up and go will be used to represent clinical outcomes of motor function and performance. The ERP recorded during Stroop color and word test and 2-Back test will be assessed together with the Montreal Cognitive Assessment (MoCA) in Thai version. Furthermore, behavoral data i.e. response time, accuracy will be collected to analyse to represent cogniton. For walking performance, dual-task interference or dual-task costs will be employed from dual-task walking. All outcomes will be assessed at baseline, post-intervention, 1-month follow-up, and 3-month follow-up.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Active HD-tDCS with conventional physical therapy and CMDT gait training
Participants will receive active tDCS for 20 minutes prior conventional physical therapy and CMDT gait training. They will be receive this intervention for 12 sessions (3 days/week for 4 weeks).
High-definition transcranial direct current stimulation (Active)
Electrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tDCS with intensity 2.0 mA for 20 minutes with 30-sec ramp-up and ramp-down.
Cognitive-motor dual task gait training
Participants will be trained in cognitive-motor dual task gait training by using Zebris Rehawalk gait analysis and gait training. Participants will be asked to walk on treadmill while response to cognitive tasks on the computer screen, which is placed in front of participants. Treadmill speed will be set according to participants' preferred speed. Cognitive tasks involve color tasks and math tasks.
Conventional Physical therapy
Conventional physical therapy starts immediately after stimulation ends. In 1-hour of conventional physical therapy involving 10 minutes of upper and lower extremity stretching, 20 minutes of upper extremity training, and 30 minutes of lower extremity training.
Active HD-tACS with conventional physical therapy and CMDT gait training
Participants will receive active tACS for 20 minutes prior conventional physical therapy and CMDT gait training. They will received this intervention for 12 sessions (3 days/week for 4 weeks).
High-definition transcranial alternating stimulation (Active)
Electrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tACS with intensity 2.0 mA for 20 minutes with frequency 70 Hz.
Cognitive-motor dual task gait training
Participants will be trained in cognitive-motor dual task gait training by using Zebris Rehawalk gait analysis and gait training. Participants will be asked to walk on treadmill while response to cognitive tasks on the computer screen, which is placed in front of participants. Treadmill speed will be set according to participants' preferred speed. Cognitive tasks involve color tasks and math tasks.
Conventional Physical therapy
Conventional physical therapy starts immediately after stimulation ends. In 1-hour of conventional physical therapy involving 10 minutes of upper and lower extremity stretching, 20 minutes of upper extremity training, and 30 minutes of lower extremity training.
Sham stimulation witn conventional physical therapy and CMDT gait training
Participants will receive sham stimulation for 30 minutes prior conventional physical therapy and CMDT gait training. They will received this intervention for 12 sessions (3 days/week for 4 weeks).
High-definition transcranial electrical stimulation (sham)
Electrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tDCS with intensity 2.0 mA for 20 minutes with electrical current flows 1-minute, with 30-second ramp-up and ramp-down, and no electrical current flow after first 1 minute to the end of stimulation.
Cognitive-motor dual task gait training
Participants will be trained in cognitive-motor dual task gait training by using Zebris Rehawalk gait analysis and gait training. Participants will be asked to walk on treadmill while response to cognitive tasks on the computer screen, which is placed in front of participants. Treadmill speed will be set according to participants' preferred speed. Cognitive tasks involve color tasks and math tasks.
Conventional Physical therapy
Conventional physical therapy starts immediately after stimulation ends. In 1-hour of conventional physical therapy involving 10 minutes of upper and lower extremity stretching, 20 minutes of upper extremity training, and 30 minutes of lower extremity training.
Interventions
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High-definition transcranial direct current stimulation (Active)
Electrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tDCS with intensity 2.0 mA for 20 minutes with 30-sec ramp-up and ramp-down.
High-definition transcranial alternating stimulation (Active)
Electrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tACS with intensity 2.0 mA for 20 minutes with frequency 70 Hz.
High-definition transcranial electrical stimulation (sham)
Electrode placement based on the international 10-20 electroencephalography electrode system. The electrode will be place over ipsilesional hemisphere on the primary motor cortex area. Anodal electrode will be placed over C3 or C4, while other 4 return electrodes will be placed over FC1/FC2, FC5/FC6, CP1/CP2, CP5/CP6. Participants will be asked to sit comfortably during stimulation. Participants will receive active HD-tDCS with intensity 2.0 mA for 20 minutes with electrical current flows 1-minute, with 30-second ramp-up and ramp-down, and no electrical current flow after first 1 minute to the end of stimulation.
Cognitive-motor dual task gait training
Participants will be trained in cognitive-motor dual task gait training by using Zebris Rehawalk gait analysis and gait training. Participants will be asked to walk on treadmill while response to cognitive tasks on the computer screen, which is placed in front of participants. Treadmill speed will be set according to participants' preferred speed. Cognitive tasks involve color tasks and math tasks.
Conventional Physical therapy
Conventional physical therapy starts immediately after stimulation ends. In 1-hour of conventional physical therapy involving 10 minutes of upper and lower extremity stretching, 20 minutes of upper extremity training, and 30 minutes of lower extremity training.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A first-ever stroke.
3. Stroke onset from at least 2 weeks-5 years.
4. Able to walk independently with or without gait aids (modified Rankin scale (mRS) 1-3)
5. Montreal cognitive Assessment-Thai version (MoCA-T) greater than or equal to 20 scores.
6. Ability to read, communicate, follow and understand instructions.
Exclusion Criteria
2. Having unstable cardiovascular disease or respiratory disease, and uncontrolled chronic disease such as diabetes mellitus (DM), hypertension (HT) and chronic kidney disease (CKD)
3. Receiving other non-invasive brain stimulation or additional intervention such as TMS, PMS or acupuncture
4. Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers.
5. Presence of an opened wound, infectious wound around scalp or craniectomy with unreplaced bone flap
6. Moderate pain (numeric pain rating score \> 4/10) in any joint of the upper or lower limb, whether paretic or non-paretic
7. Presence of color blindness
8. Presence of any substance use including cannabis and kratom
18 Years
80 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Locations
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Faculty of Physical Therapy, Mahidol University
Nakhon Pathom, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MU-CIRB 2025/304.1106
Identifier Type: -
Identifier Source: org_study_id
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