Effects of tES Combined With CMDT Gait Training on Cognition, Cortical Activity, Spinal Motoneuron Excitability and Motor Performance in Stroke Individuals

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMahidol University

About this trial

The present study will use transcranial electrical stimulation (tES) which are transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS) combined with conventional physical therapy and cognitive-motor dual task gait training in sub-acute (at least 2 weeks after stroke onset) to chronic (within 5 years post-stroke) to investigate the effect on cortical activity, spinal motoneuron excitability, cognition and motor performance. The findings may enhance the evidence to support usages of tES for improvimg cognition, motor performance as well as cortical activity and spinal motoneuron excitability in a clinical setting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Unilateral stroke individuals aged 18-80 years.

A first-ever stroke.

Stroke onset from at least 2 weeks-5 years.

Able to walk independently with or without gait aids (modified Rankin scale (mRS) 1-3)

Disqualifiers

Presence of any psychological or neurological antecedent, unstable medical conditions or condition that may increase risk of stimulation such as epilepsy, seizure, and history of brain injury

Having unstable cardiovascular disease or respiratory disease, and uncontrolled chronic disease such as diabetes mellitus (DM), hypertension (HT) and chronic kidney disease (CKD)

Receiving other non-invasive brain stimulation or additional intervention such as TMS, PMS or acupuncture

Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers.

Trial design

Design model

Factorial

Treatments tested in this trial

  • High-definition transcranial direct current stimulation (Active)

    Device

    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)

    Device

    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)

    Device

    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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Active HD-tDCS with conventional physical therapy and CMDT gait trainingExperimental treatment 3 interventions
Group B: Active HD-tACS with conventional physical therapy and CMDT gait trainingExperimental treatment 3 interventions
Group C: Sham stimulation witn conventional physical therapy and CMDT gait trainingSham comparator 3 interventions

Trial outcomes

Primary outcomes

1

Fugl-Meyer assessment (FMA) of upper and lower extremities

The FMA is a clinical assessment that quantified level of motor impairement and evaluate recovery in post-stroke. The FMA Includes 33 items for the upper extremity and 17 items for the lower extremity, totaling 100 points. Higher scores indicate better motor performance.

Time frame
Baseline, 1-day post-intervention, 1-month follow-up, and 3-month follow-up

Secondary outcomes

1

Event Related Potential (ERP)

ERP is a non-invasive measurement tool that detects a very small voltage generated by brain activity in response to a specific event (i.e. Stroop test, N-back test). This is a signal averaging form of EEG that detects signals starting from the onset of a stimulus to evaluate brain responses over time, those occurring at 200 milliseconds (P200), or 300 milliseconds (P300) .

Time frame
Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
2

Absolute power

The raw data from electroencephalographyt (EEG) in 5-min of eye-open and eye-close conditions converted to the power distribution of brain waves in different frequencies (i.e. delta, theta, and beta) usign a Fast Fourier Transformation (FFT)

Time frame
Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
3

Montreal Cognitive Assessment

The Montreal Cognitive Assessment (MoCA) is used to assess cognitive functioning in eight domains: Visuospatial and executive function, Naming, Attention, Language, Abstraction, Delayed recall, Orientation, Short-term memory. Participants are instructed to complete both paper-based and verbal question-answering activities, such as drawing pictures, sorting numbers, naming animals, and reviewing vocabulary. The maximum total score is 30 points, with a high score indicating a good level of cognitive.

Time frame
Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up
4

Timed up and go test

Participants wear regular footware and if they have normally used gait aid, it is allowed to use in the test. The test measures the time taken when the participants stand up from the chair, walk at normal pace for 3 meters, turn around, walk back for 3 meters, and then sit on a chair.

Time frame
Baseline, 1-day post-intervention, 1-month follow-up and 3-month follow-up

Other outcomes

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