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Stroke, AcuteNCT05332652

Establishing a Prognostic Model for Stroke Recovery

A study testing trancranial magnetic stimulation in people with Stroke, Acute, run by National University Hospital, Singapore at 2 sites in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This main aim of the study is to investigate the changes in neurophysiological features after stroke, and its association with upper limb motor recovery, so as to establish a prognostic model for upper limb motor recovery after stroke. Read more about this study

Who is it for?
Ages 21 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Acute
What is being tested?
trancranial magnetic stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
2 sitesSingapore
Study dates
1 Sep 2020to 16 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 21 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 21-80 years old;
  • First ever stroke less than 6 weeks;
  • Moderate to severe upper limb impairment with Manual Muscle Testing (MMT) score on shoulder abduction plus finger extension (SAFE) <5 within the first week post-stroke.
  • Age 21-80 years old;
  • No known medical history.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.
  • Pregnancy;
  • Any metal implants inside the body that are contraindications of MRI scan;
  • cardiac pacemakers;
  • Claustrophobia.

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites
  • Alexandra Hospital

    Singapore

  • National University Hospital

    Singapore

Other trials in Singapore

About this study

Official title: Neural Network Reorganization Associated With Upper Limb Motor Recovery in Stroke Patients- Establishing a Prognostic Model and Tailoring Neuromodulation for Rehabilitation

This main aim of the study is to investigate the changes in neurophysiological features after stroke, and its association with upper limb motor recovery, so as to establish a prognostic model for upper limb motor recovery after stroke. The investigators hypothesize that a combination of neurophysiological features measured by transcranial magnetic stimulation (TMS), high density electroencephalography (HD-EEG), functional magnetic resonance imaging (fMRI) and Diffusion Tensor Imaging (DTI) might be used as biomarkers to predict upper limb motor outcomes after stroke. The investigators also hypothesize that non-invasive brain stimulation strategies such as tDCS will more effectively improve motor outcomes as an adjunct to therapy, if tailored according to patient's predicted pattern of neural reorganization.

Read the detailed description

This study comprises 2 parts. Study 1 is a longitudinal cohort study to characterize the neurophysiological changes with upper limb motor recovery in stroke patients with moderate to severe upper limb motor function impairment, and its correlation with motor function recovery.

120 stroke subjects within 3 weeks post-stroke will be recruited from National University Hospital (NUH), Alexandra Hospital (AH), and Tan Tock Seng Hospital (TTSH). We will follow changes in cortical activity over time using Transcranial Magnetic Stimulation (TMS), MRI and EEG measures and correlate these with clinical outcome measures at the same time points, to study the interaction between neural excitability and functional outcome.

10 healthy subjects will be needed as control group to compare outcomes obtained from MRI scans.

Outcome measures of brain corticospinal excitability, clinical measures on upper limb motor function and cognitive tests, will be performed 4 times- within 4 weeks, at 3 months, 6 months and 1 year after stroke onset, except for MRI which will not be performed at 1 year after stroke onset.

Subjects from Study 1 whose ARAT (Action Research Arm test) score is < = 42 at 3 months post-stroke will proceed to Study 2. ARAT score < = 42 indicates limited functional capacity and below. The aim of Study 2 is to investigate the efficacy and the neurophysiological effects of 2 types of tDCS protocols in facilitating upper limb motor recovery in patients with significant limitations in upper limb function.

There are a total of 4 groups in Study 2. Subjects who are agreeable for transcranial direct current stimulation (tDCS) will be randomized into 3 groups with 17 subjects in each group, by stratified randomization using Microsoft Excel, according to the lesion location (cortical vs. subcortical), and type of stroke (haemorrhagic vs. ischemic). Subjects who refuse tDCS will be enrolled in the control group without receiving any tDCS stimulation.

  • 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.
  • Group 4: Subjects who fulfill the inclusion criteria of Study 2 but refuse tDCS stimulation.

Cathode for all 3 tDCS groups 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. Subjects in Study 2 will continue with the 6-month and 1 year assessment, as in Study 1.

Conditions
Stroke, Acute
Being tested
trancranial magnetic stimulation
Keywords
stroke, motor recovery, prognostic model, transcranial magnetic stimulation, transcranial direct current stimulation, neuromodulation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trancranial magnetic stimulationDevice

    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.

Study groups in NCT05332652
Study groupRoleWhat they receive
Anodal tDCS stimulation to the ipsilesional M1ExperimentalParticipant 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.
Receives: Device: trancranial magnetic stimulation
Anodal tDCS to the contralesional premotor cortexExperimentalParticipant 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.
Receives: Device: trancranial magnetic stimulation
Sham tDCSSham comparatorParticipant 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.
Receives: Device: trancranial magnetic stimulation
Control groupNo interventionSubjects who fulfill the inclusion criteria of Study 2 but refuse tDCS stimulation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of cortical excitability using Transcranial Magnetic Stimulation (TMS)

    measures of cortical excitability for those without TMS contraindications

    Measured: Change of the cortical excitability within 4 weeks, at 3 months, 6 months and 1 year after stroke onset

  2. Change of neural excitability using 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.

    Measured: Change of the neural excitability within 4 weeks, at 3 months, 6 months after stroke onset

  3. Change of neural excitability using electroencephalogram (EEG)

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

    Measured: Change of the neural excitability within 4 weeks, at 3 months, 6 months and 1 year after stroke onset

  4. Change of the 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.

    Measured: Change of the upper extremity motor function within 4 weeks, at 3 months, 6 months and 1 year after stroke onset

  5. Change of upper extremity performance (coordination, dexterity and functioning) using Action Research Arm Test

    Upper limb function, Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.

    Measured: Change of upper extremity performance within 4 weeks, at 3 months, 6 months and 1 year after stroke onset

  6. Change of muscle spasticity using Modified Ashworth scale for spasticity (MAS)

    Upper limb function, 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.

    Measured: Change of muscle spasticity within 4 weeks, at 3 months, 6 months and 1 year after stroke onset

Secondary outcomes (1)
  1. Change of cognitive function using cognitive test

    The following cognitive test will be performed to assess cognitive function :

    • Digit Span Task
    • Digit Symbol Substitution Task
    • Trail-making test (TMT)-A \&B
    • Clock-Drawing Test (CDT)
    • Controlled Oral Word Association Test (COWAT) -animals \& FAS
    • Mini-Mental State Exam (MMSE)
    • Rey Auditory Verbal Learning Test (RAVL)
    • Spatial span forward/backward test
    • Visuospatial Paired Associate Learning (VPA)

    Measured: Change of cognitive function within 4 weeks, at 3 months, 6 months and 1 year after stroke onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start1 Sep 2020
  3. Primary completion16 Jul 2026 (estimated)
  4. Study completion16 Jul 2026 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects from Study 1 whose ARAT score is \< = 42 at 3 months post-stroke will proceed to Study 2. Subjects who are agreeable for transcranial direct current stimulation (tDCS) will be randomized into 3 groups with 17 subjects in each group, by stratified randomization, according to the lesion location (cortical vs. subcortical), and type of stroke (haemorrhagic vs. ischemic). Subjects who refuse tDCS will be enrolled in the control group without receiving any tDCS stimulation. * 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. * Group 4: Subjects who fulfill the inclusion criteria of Study 2 but refuse tDCS stimulation.
Masking
Single blind
Who is masked
Participant
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05332652
Sponsor's protocol ID
2019/00932
Other IDs
2019
Status last verified
Sep 2025
First submitted
13 Sep 2021
Last updated
20 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing trancranial magnetic stimulation in people with Stroke, Acute, run by National University Hospital, Singapore at 2 sites in Singapore.

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 5 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change of cortical excitability using Transcranial Magnetic Stimulation (TMS) (time frame: Change of the cortical excitability within 4 weeks, at 3 months, 6 months and 1 year after stroke onset). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Feb 2026.

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