Stroke, IschemicNCT04724824
Validation of a Brain-Computer Interface for Stroke Neurological Upper Limb Rehabilitation
A study testing Brain-Computer Interface in people with Stroke, Ischemic and Stroke, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
Trial summary
The study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke
- What is being tested?
- Brain-Computer Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteMexico
- Study dates
- 16 Mar 2021to 24 Jun 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of first ischemic stroke
- Time since stroke onset higher than 3 months and lower than 24 months
- Hand paresis
- Normal or corrected to normal vision
- Without previous diagnosed neurological diseases
Who cannot join
- Clinical diagnosis of severe aphasia
- Clinical diagnosis of severe depression
- Clinical diagnosis of severe attention deficits
- Previous diagnosis of traumatic brain injury
- Previous diagnosis of spinal cord injury
- Previous diagnosis of peripheral nerve injury
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
Tlalpan, Mexico City, 14389
About this study
Official title: Validation of a Brain-Computer Interface for Neurorehabilitation With a Randomized Controlled Trial (Validación de Una Interfaz Cerebro-Computadora Para Rehabilitación Neurológica Por Medio de un Ensayo Clínico Controlado y Aleatorizado)
The study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. For this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.
- Conditions
- Stroke, Ischemic, Stroke
- Being tested
- Brain-Computer Interface, Sham Brain-Computer Interface
- Keywords
- brain-computer interface, robotic orthosis, hemiparesis, motor rehabilitation
- Medical subject headings
- Ischemic Stroke, Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Computer InterfaceDevice
Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis that will be activated by the brain-computer interface based on hand movement intention.
Sham Brain-Computer InterfaceDevice
Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis which activation will be independent of the output of the brain-computer interface based on hand movement intention.
| Study group | Role | What they receive |
|---|---|---|
| Brain-Computer Interface controlled robotic feedback | Experimental | Not described Receives: Device: Brain-Computer Interface |
| Sham Brain-Computer Interface controlled robotic feedback | Sham comparator | Not described Receives: Device: Sham Brain-Computer Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
Analysis of changes on the Fugl-Meyer Assessment for the Upper Extremity will reveal if there is a clinical significant sensorimotor function compared to baseline
Measured: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Mean change from baseline in upper limb motor function on the Action Research Arm Test
Analysis of changes on the Action Research Arm Test will reveal if there is a clinical significant motor function compared to baseline
Measured: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Secondary outcomes (3)
Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging
Blood-oxygen-level-dependent imaging will be analyzed to assess if there are changes in cortical activity compared to baseline.
Measured: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation
Motor Evoked Potentials parameters will reveal if there are changes of corticospinal excitability in both hemibodies compared to baseline
Measured: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Mean change from baseline in grip strength measured with a dynamometer
Analysis of hand strength measurements will reveal if there were changes compared to baseline
Measured: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start16 Mar 2021
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Collaborators
- National Council of Science and Technology, Mexico, Hospital General Dr. Manuel Gea González, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Responsible party
- Principal investigator, Jessica Cantillo-Negrete, Instituto Nacional de Rehabilitacion
- Investigators
- Jessica Cantillo-Negrete, PhD, Principal investigator, Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724824
- Sponsor's protocol ID
- SALUD-2018-02-B-S-45803
- Status last verified
- Jul 2024
- First submitted
- 22 Jan 2021
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the study will be available to other researchers from the principal investigator on reasonable request.
Publications
Cantillo-Negrete J, Rodriguez-Garcia ME, Carrillo-Mora P, Arias-Carrion O, Ortega-Robles E, Galicia-Alvarado MA, Valdes-Cristerna R, Ramirez-Nava AG, Hernandez-Arenas C, Quinzanos-Fresnedo J, Pacheco-Gallegos MDR, Marin-Arriaga N, Carino-Escobar RI. The ReHand-BCI trial: a randomized controlled trial of a brain-computer interface for upper extremity stroke neurorehabilitation. Front Neurosci. 2025 Jun 18;19:1579988. doi: 10.3389/fnins.2025.1579988. eCollection 2025.
PubMed 40606836Rodriguez-Garcia ME, Carino-Escobar RI, Carrillo-Mora P, Hernandez-Arenas C, Ramirez-Nava AG, Pacheco-Gallegos MDR, Valdes-Cristerna R, Cantillo-Negrete J. Neuroplasticity changes in cortical activity, grey matter, and white matter of stroke patients after upper extremity motor rehabilitation via a brain-computer interface therapy program. J Neural Eng. 2025 Mar 20;22(2). doi: 10.1088/1741-2552/adbebf.
PubMed 40064104
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Brain-Computer Interface for Neurorehabilitation With a Randomized Controlled Trial (Validación de Una Interfaz Cerebro-Computadora Para Rehabilitación Neurológica Por Medio de un Ensayo Clínico Controlado y Aleatorizado)
- ClinicalTrials.gov ID
- NCT04724824
- Acronym / sponsor ID
- SALUD-2018-02-B-S-45803
- Conditions
- Stroke, Ischemic, Stroke
- Keywords
- brain-computer interface, robotic orthosis, hemiparesis, motor rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Collaborators
- National Council of Science and Technology, Mexico, Hospital General Dr. Manuel Gea González, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. For this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain-Computer Interface controlled robotic feedback | Experimental | Device: Brain-Computer Interface |
| Sham Brain-Computer Interface controlled robotic feedback | Sham comparator | Device: Sham Brain-Computer Interface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of first ischemic stroke
- Time since stroke onset higher than 3 months and lower than 24 months
- Hand paresis
- Normal or corrected to normal vision
- Without previous diagnosed neurological diseases
Key exclusion criteria (6 listed)
- Clinical diagnosis of severe aphasia
- Clinical diagnosis of severe depression
- Clinical diagnosis of severe attention deficits
- Previous diagnosis of traumatic brain injury
- Previous diagnosis of spinal cord injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain-Computer InterfacePassive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis that will be activated by the brain-computer interface based on hand movement intention. | Device | Brain-Computer Interface controlled robotic feedback |
| Sham Brain-Computer InterfacePassive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis which activation will be independent of the output of the brain-computer interface based on hand movement intention. | Device | Sham Brain-Computer Interface controlled robotic feedback |
Primary outcome
Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Analysis of changes on the Fugl-Meyer Assessment for the Upper Extremity will reveal if there is a clinical significant sensorimotor function compared to baseline
Mean change from baseline in upper limb motor function on the Action Research Arm Test
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Analysis of changes on the Action Research Arm Test will reveal if there is a clinical significant motor function compared to baseline
3 secondary outcomes
Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Mean change from baseline in grip strength measured with a dynamometer
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 40606836Cantillo-Negrete J, Rodriguez-Garcia ME, Carrillo-Mora P, Arias-Carrion O, Ortega-Robles E, Galicia-Alvarado MA, Valdes-Cristerna R, Ramirez-Nava AG, Hernandez-Arenas C, Quinzanos-Fresnedo J, Pacheco-Gallegos MDR, Marin-Arriaga N, Carino-Escobar RI. The ReHand-BCI trial: a randomized controlled trial of a brain-computer interface for upper extremity stroke neurorehabilitation. Front Neurosci. 2025 Jun 18;19:1579988. doi: 10.3389/fnins.2025.1579988. eCollection 2025.
- Derived from this study: PubMed 40064104Rodriguez-Garcia ME, Carino-Escobar RI, Carrillo-Mora P, Hernandez-Arenas C, Ramirez-Nava AG, Pacheco-Gallegos MDR, Valdes-Cristerna R, Cantillo-Negrete J. Neuroplasticity changes in cortical activity, grey matter, and white matter of stroke patients after upper extremity motor rehabilitation via a brain-computer interface therapy program. J Neural Eng. 2025 Mar 20;22(2). doi: 10.1088/1741-2552/adbebf.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the study will be available to other researchers from the principal investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Cantillo-Negrete, PhD principal investigator
Instituto Nacional de Rehabilitacion (National Institute of Rehabilitation)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-Computer Interface in people with Stroke, Ischemic and Stroke, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
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 6 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: finished, as of the sponsor's last update on 12 Jul 2024. 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity (time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset). The study lists 2 primary outcomes in all. 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 NCT04724824, which also lists 2 linked publications.
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 12 Jul 2024.