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NCT05634616: BCI-MIME
Motor Imagery and Motor Execution Based BCI in Stroke
NA trial testing Motor imagery and motor execution based BCI in Stroke in 40 participants. Status unknown.
30 June 2023
Quick facts
| Lead sponsor | First Affiliated Hospital Xi'an Jiaotong University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 24 November 2022 |
| Primary completion | 30 June 2023 |
| Estimated completion | 31 July 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Motor imagery and motor execution based BCI
- Sham BCI
Conditions studied
- Stroke — all drugs for Stroke →
- Neurorehabilitation — all drugs for Neurorehabilitation →
- Motor Imagery — all drugs for Motor Imagery →
- Motor Execution — all drugs for Motor Execution →
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Who can join
Adults 35 to 79, any sex, with Stroke or Neurorehabilitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
About 50% of stroke patients are unable to live independently because of residual disability. Brain-computer interface (BCI) is based on closed-loop theory, which facilitates neurological remodeling by establishing a bridge between central and peripheral connections. Studies have confirmed that BCI real-time neurofeedback training system based on motor imagery alone can effectively improve patients' motor function. So, is the benefit greater if motor imagery is combined with motor execution? Current conclusions are mixed. In addition, previous studies and our preliminary study found that prefrontal Fp1 and Fp2 areas play an important role in motor recovery after stroke, and they are involved in motor imagery, motor execution, attention and other behavioral processes. Therefore, we designed a BCI training system based on motor imagery and motor execution with prefrontal electroencephalogram (EEG) signals as the modulatory target. This was a randomized placebo-controlled double-blinded clinical trial. Patients in the test group performed BCI-controlled upper extremity motor imagery + upper extremity pedaling training. The control group had the same equipment and training scenario, and patients were also asked to imagine the upper extremity pedaling movement with effort, and patients also wore EEG caps, but the EEG signals were only recorded without controlling the pedaling equipment. After 3 weeks of treatment, we observed the changes of motor and cognitive functions as well as fNIRS-related brain network characteristics in both groups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05634616
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05634616 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital Xi'an Jiaotong University
- Last refreshed: 2 December 2022
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