Evaluating Different Protocols of Non-invasive Brain Stimulation (NIBS) in Stroke Rehabilitation

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorNational University Hospital, Singapore

About this trial

This study aims to improve brain stimulation techniques for stroke patients dealing with motor and language issues. Researchers believe that current practices lack clarity because patients aren't grouped effectively and stimulation methods vary widely.

The study will include 250 participants from Alexandra Hospital and National University Hospital. Once someone is eligible and agrees to join, they'll first undergo a baseline assessment to evaluate their condition. After that, they'll receive non-invasive brain stimulation (NIBS) over the course of a month.

Participants will be assigned to specific NIBS treatments-either transcranial direct current stimulation (tDCS) or repetitive transcranial magnetic stimulation (rTMS)-based on their rehabilitation goals, medical history, and initial assessment results. Those needing to improve upper or lower limb movement, alleviate language difficulties (aphasia), or address neglect will receive tailored interventions: 20 sessions of tDCS or 12 sessions of rTMS.

After the treatment, participants will be assessed again immediately and then six weeks later to measure any changes in their condition.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 21-80 years old;

Diagnosis of stroke, with good premorbid function.

Disqualifiers

Pregnancy;

cardiac pacemakers;

Sensorimotor disturbance due to other causes other than stroke;

Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;

Trial design

Design model

Single group

Treatments tested in this trial

  • noninvasive brain stimulation (NIBS) including transcranial direct current stimulation (tDCS) and repetitive TMS (rTMS)

    Device

    The NIBS devices used in this study are tDCS (1. Newronikia, Italy; 2. Magstim, UK) and DuoMag TMS (Deymed, Czech). All are commercialized in market. 20 sessions of tDCS, or 12 sessions of rTMS will be conducted over 1 month for NIBS intervention.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: non-invasive brain stimulation (NIBS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Upper Extremity Fugl-Meyer Assessment (UE-FMA)

UE-FMA is a standardized, performance-based impairment index used to evaluate motor recovery following a stroke. The score ranges from 0 to 66. Higher score indicates higher function.

Time frame
Week 0
2

Upper Extremity Fugl-Meyer Assessment (UE-FMA)

UE-FMA is a standardized, performance-based impairment index used to evaluate motor recovery following a stroke. The score ranges from 0 to 66. Higher score indicates higher function.

Time frame
after NIBS, up to 6 weeks
3

Upper Extremity Fugl-Meyer Assessment (UE-FMA)

UE-FMA is a standardized, performance-based impairment index used to evaluate motor recovery following a stroke. The score ranges from 0 to 66. Higher score indicates higher function.

Time frame
follow-up, 6 weeks to 6 months after NIBS
4

Action Research Arm test (ARAT)

ARAT is a 19-item test used to evaluate upper extremity function, with scores ranging from a minimum of 0 to a maximum of 57. Higher scores on the ARAT indicate better functional performance, while lower scores indicate greater impairment.

Time frame
Week 0

Secondary outcomes

1

Modified Ashworth scale (MAS) of the affected muscles

Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.

Time frame
Week 0
2

Modified Ashworth scale (MAS) of the affected muscles

Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.

Time frame
after NIBS, up to 6 weeks
3

Modified Ashworth scale (MAS) of the affected muscles

Test for muscle spasticity, score ranges from 0 to 4, with higher score indicating worse outcome.

Time frame
follow-up, 6 weeks to 6 months after NIBS
4

Coherence measured by HD-EEG

Coherence measures the consistency of phase and amplitude between two brain regions, indicating how effectively they are communicating. It is a primary indicator of functional connectivity:

Time frame
Week 0

Other outcomes

Sponsors and contacts

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