Upper Limb tDCS in Chronic Stroke Patients (NOURISH)

NCT05608525 | Completed DMC

• 1 other identifier: 2022/00686
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized double-blinded trial investigating the effect of Transcranial Direct Current stimulation (tDCS) on upper limb motor function rehabilitation in chronic stroke patients. 51 subjects will be recruited from National University Hospital (NUH) and be randomized to receive one of the followings:

• Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb;
• Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex;
• Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1. tDCS will be performed once a day together with standardized occupational therapy (GRASP) for 20 sessions within 30 days. Group 1 and Group 2 will receive tDCS for 20 minutes during each session, while Group 3 only receives the current stimulation for 20 seconds. GRASP will be performed daily together with tDCS, either concurrently with or immediately after tDCS stimulation. The outcome measures will be measured at baseline, after intervention and 1 month after intervention, including:
• TMS measurement of corticospinal excitability;
• functional MRI scan;
• High density EEG (HD-EEG) evaluation;
• Clinical measures on upper limb motor function;
• Cognitive tests.

Conditions

Stroke

Keywords

stroke; motor recovery; transcranial direct current stimulation; corticospinal excitability; neuromodulation

Outcome Measures

Primary Outcomes (17)

• Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)

  measures of cortical excitability for those without TMS contraindications

  Month 0

• Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)

  measures of cortical excitability for those without TMS contraindications

  Month 1

• Cortical excitability measured by Transcranial Magnetic Stimulation (TMS)

  measures of cortical excitability for those without TMS contraindications

  Month 2

• neural excitability measured by Magnetic resonance imaging (MRI) scan

  Participants will go through one of the following image acquisition procedures 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version.

  Month 0

• neural excitability measured by Magnetic resonance imaging (MRI) scan

  Participants will go through one of the following image acquisition procedures 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version.

  Month 2

• neural excitability measured by electroencephalogram (EEG)

  High density EEG (electroencephalogram) evaluation of the electrical activity of the brain

  Month 0

• neural excitability measured by electroencephalogram (EEG)

  High density EEG (electroencephalogram) evaluation of the electrical activity of the brain

  Month 1

• neural excitability measured by electroencephalogram (EEG)

  High density EEG (electroencephalogram) evaluation of the electrical activity of the brain

  Month 2

• upper extremity motor function using Fugl-Meyer scale

  Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.

  Month 0

• upper extremity motor function using Fugl-Meyer scale

  Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.

  Month 1

• upper extremity motor function using Fugl-Meyer scale

  Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.

  Month 2

• Action Research Arm Test

  Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.

  Month 0

• Action Research Arm Test

  Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.

  Month 1

• Action Research Arm Test

  Test for upper extremity performance (coordination, dexterity and functioning). Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.

  Month 2

• Modified Ashworth scale for spasticity (MAS)

  Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.

  Month 0

• Modified Ashworth scale for spasticity (MAS)

  Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.

  Month 1

• Modified Ashworth scale for spasticity (MAS)

  Test for muscle spasticity. 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.

  Month 2

Study Arms (3)

Anodal tDCS stimulation to the ipsilesional M1

EXPERIMENTAL

Participant will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.

Device: transcranial current stimulation; Behavioral: GRASP

Anodal tDCS to the contralesional premotor cortex

EXPERIMENTAL

Participant will receive 1mA anodal tDCS to the contralesional premotor cortex. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.

Device: transcranial current stimulation; Behavioral: GRASP

Sham tDCS

SHAM COMPARATOR

Participant will receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.

Device: transcranial current stimulation; Behavioral: GRASP

Interventions

transcranial current stimulation DEVICE

A trained research staff or physician will perform tDCS to the subject. Direct current will be delivered by a battery-operated, constant current stimulator, through 2 rubber electrodes embedded in a pair of saline-soaked sponge bag. Stimulation intensity will be ramped up to 1 mA over 30 seconds and maintain at 1 mA for 20 minutes, and then ramped down to 0 mA over 30 seconds.

Anodal tDCS stimulation to the ipsilesional M1; Anodal tDCS to the contralesional premotor cortex; Sham tDCS

GRASP BEHAVIORAL

A standardized occupational therapy- GRASP will be performed daily together with tDCS over the period between the Pre Assessment and the Post Assessment. GRASP exercise will be administered concurrently with or immediately after tDCS stimulation. GRASP is a self-directed arm and hand exercise program for which is supervised by a therapist, but done independently by the participant (and with their family if possible). GRASP has been shown to improve arm and hand function and strength in stroke patients in community \[22-27\]. The versions of the program- Home GRASP will be used. All occupational tasks will be selected from the GRASP task pool and be progressed according to the GRASP protocol (https://neurorehab.med.ubc.ca/grasp). Each GRASP session will take about 1 hour. A total of 20 GRASP sessions will be administered.

Anodal tDCS stimulation to the ipsilesional M1; Anodal tDCS to the contralesional premotor cortex; Sham tDCS

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-80 years old;
• First ever stroke, 6 months to 2 years after stroke onset;
• ARAT≤42

You may not qualify if:

• Pregnancy;
• Any metal implants inside the body that are contraindications of MRI scan;
• cardiac pacemakers;
• History of epilepsy;
• Sensorimotor disturbance due to other causes other than stroke;
• Claustrophobia;
• Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
• Major depression and a history of psychotic disorders;
• Terminal diagnosis with life expectancy \<=1 year. Any metal implants inside the body that are contraindications of MRI scan;
• \. cardiac pacemakers; 4. History of epilepsy; 5. Sensorimotor disturbance due to other causes other than stroke; 6. Claustrophobia; 7. Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina; 8. Major depression and a history of psychotic disorders; 9. Terminal diagnosis with life expectancy \<=1 year.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation; Hand Strength

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Effie Chew, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and outcome assessor will be blinded to the tDCS stimulation protocol that they will be receiving.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive one of the followings: * Group 1 will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb; * Group 2 to receive 1mA anodal tDCS to the contralesional premotor cortex; * Group 3 to receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: February 16, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 23, 2026

Record last verified: 2025-09

Locations

SG (1)