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StrokeNCT04465786

A Closed-loop Brain-computer Interface for Stroke

An observational study of Stroke, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It may be hard to acquire stable sensorimotor rhythm from the affected motor cortex for patient without a response of paretic hand. A few studies suggest two ways to approaching closed-loop therapy: peripherally extracting the residual signals, for example electromyogram (EMG) at proximal muscles (deltoids) and… Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
How many people
70 participants
Where
1 siteTaiwan
Study dates
13 Jul 2020to 31 Aug 2022
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Hospitalized participants and healthy controls will be recruited from the Taipei Veterans General Hospital.

Who may be able to join

  • first-ever, unilateral infarction or hemorrhage at middle cerebral artery or posterior cerebral artery territory
  • early subacute phase of stroke (between 1 and 4 weeks after stroke onset)

Who cannot join

  • electroencephagraphy feature is not usable
  • Fugl-Meyer Assessment of Upper Extremity score is over 50
  • ataxia
  • global aphasia
  • concomitant neurological diseases
  • psychiatric diseases
  • participating in other interventional research during this period
  • other conditions might interfere with experiment

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting

  • Taipei Veterans General Hospital

    Taipei, 112

    i-hui Lee, MD, PhD, 886-2-28712121 ext. 8109, ihui_lee@hotmail.com

    i-hui Lee, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: A Closed-loop Brain-computer Interface for Paretic Hand Stimulation After Stroke

It may be hard to acquire stable sensorimotor rhythm from the affected motor cortex for patient without a response of paretic hand. A few studies suggest two ways to approaching closed-loop therapy: peripherally extracting the residual signals, for example electromyogram (EMG) at proximal muscles (deltoids) and centrally extracting the activity patterns from unaffected hemisphere during attempting to move paretic hand. Therefore, understanding neural signatures of residual upper extremity movement among stroke patients might help in discovering potential therapeutic target and developing tailored brain-computer interface (BCI) therapy. Additionally, 59.4% of stroke patients in acute stage impair at least one somatosensory modality. It remains unclear whether the patient with somatosensory impairment hinder BCI effect.

Read the detailed description

Investigators will consecutively enroll subacute (1-4 weeks after stroke onset) patients with first-time, unilateral, subcortical stroke and age-matched healthy controls. All participants will carry on 2 sequential experiments. In the first experiment, participants will perform 2 motor tasks using either paretic/nondominant upper extremity or non-paretic/dominant upper extremity, called motor attempt (M) condition or calibration condition. The second experiment contains 3 conditions: cyclic functional electrical stimulation (cFES), cFES during motor attempt (M-cFES), and functional electrical stimulation during brain-computer interface (BCI-FES) in random order. The sensorimotor oscillations from the electroencephalography (EEG), upper extremity sensorimotor function score (Fugl-Meyer test, Action Research Arm test, and Revised Nottingham Sensation Assessment), corticospinal excitability from the transcranial magnetic stimulation (TMS), and resting-state functional and structural neuroimage from magnetic resonance imaging (MRI) will be assessed before and after the final experiment, as well as 3 months after stroke.

Conditions
Stroke
Keywords
Stroke, Sensorimotor rhyme, Brain-computer interface
Medical subject headings
Stroke

What is being measured

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

  1. Sensorimotor rhythms

    electroencephalography

    Measured: Baseline, during experimental procedures

Secondary outcomes (7)

  1. Fugl-Meyer Assessment

    Fugl-Meyer Assessment (FMA) measures both upper-limb and lower-limb motor function. The total score of FMA ranges from 0 to 100, which higher score indicates better motor recovery.

    Measured: At baseline (1-4 week of stroke) and at 3 months after stroke

  2. Action Research Arm test

    Action Research Arm test (ARAT) measures specific upper-limb and hand function. The total score of ARAT ranges from 0 to 57, which higher score indicates better motor function.

    Measured: At baseline (1-4 week of stroke) and at 3 months after stroke

  3. Revised Nottingham Sensation Assessment

    Revised Nottingham Sensation Assessment (rNSA) measures various upper-limb sensory function. The total score of rNSA ranges from 0 to 151, which higher score indicates better somatosensory function.

    Measured: At baseline (1-4 week of stroke) and at 3 months after stroke

  4. Motor Activity Log

    Motor Activity Log (MAL) measures real-use of upper-limb. The averaged index of MAL ranges from 0 to 5, which higher index indicates more frequently use of paretic upper limb.

    Measured: At baseline (1-4 week of stroke) and at 3 months after stroke

  5. Resting motor threshold

    Transcranial magnetic stimulation test

    Measured: At baseline (1-4 week of stroke) and at 3 months after stroke

  6. Motor evoked potential

    Transcranial magnetic stimulation test

    Measured: At baseline (1-4 week of stroke) and at 3 months after stroke

  7. Resting-state brain connectivity

    Magnetic resonance imaging

    Measured: At baseline (1-4 week of stroke) and at 3 months after stroke

Timeline

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

  1. First posted10 Jul 2020
  2. Study start13 Jul 2020 (estimated)
  3. Primary completion31 Aug 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
70 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04465786
Sponsor's protocol ID
2019-08-017B
Status last verified
Jul 2020
First submitted
20 Apr 2020
Last updated
10 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensorimotor rhythms (time frame: Baseline, during experimental procedures). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04465786.

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 10 Jul 2020.

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A Closed-loop Brain-computer Interface for Stroke | AzTrials