Cervical Spinal Cord InjuryNCT05343130
Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation
A study testing Brain-Computer Interface in people with Cervical Spinal Cord Injury, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
Trial summary
The study's main goal is to determine the efficacy of a therapy with brain-computer interface controlled functional electrical stimulation for neurorehabilitation of spinal cord injury patients' upper limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spinal Cord Injury
- 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
- 32 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2022to Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal Cord Injury at neurological levels C6 or C7
- American Spinal Injury Association (ASIA) classification A, B, C or D
- Upper limb spasticity of less or equal to +1 measured with the Modified Ashworth Scale
- Time since disease onset of more than 6 months and less than 60 months
- Normal or corrected to normal vision
Who cannot join
- Severe attention deficits
- Previous diagnosis of traumatic brain injury
- Previous diagnosis of peripheral nerve injury
- Previous stroke diagnosis
- Previous diagnosis of neurodegenerative diseases
- History of fractures in upper extremities
Show all 9Show fewer
- Skin lesions
- Contractures in upper extremities that hamper mobility
- Excessive muscle spasms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
Tlalpan, Mexico City, 14389
Jessica Cantillo-Negrete, PhD, +52 55 59991000 ext. 19008, jcantillo@inr.gob.mx
Ruben I. Carino-Escobar, PhD, +52 55 59991000 ext. 19008, ricarino@inr.gob.mx
About this study
Official title: Efficacy of a Therapy With Brain-Computer Interface Controlled Functional Electrical Stimulation for Neurorehabilitation of Patients With Spinal Cord Injury (Eficacia de Una Terapia Con estimulación eléctrica Funcional Controlada Con Interfaz Cerebro-computadora Para neurorrehabilitación de Pacientes Con lesión Medular)
The study's main goal is to determine the efficacy of a therapy with brain-computer interface controlled functional electrical stimulation for neurorehabilitation of spinal cord injury patients' upper limbs. For this purpose, a randomized controlled trial will be performed to compare the clinical and physiological effects of the brain-computer interface therapy with those of a sham intervention comprised by the application of functional electrical stimulation independently of brain-computer interface control.
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- Brain-Computer Interface, Sham Brain-Computer Interface
- Keywords
- brain-computer interface, functional electrical stimulation, motor rehabilitation, tetraplegia
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Computer InterfaceDevice
Hand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention.
Sham Brain-Computer InterfaceDevice
Hand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention.
| Study group | Role | What they receive |
|---|---|---|
| Brain-Computer Interface controlled functional electrical stimulation feedback | Experimental | Not described Receives: Device: Brain-Computer Interface |
| Sham Brain-Computer Interface controlled functional electrical stimulation 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.
Action Research Arm Test (ARAT)
Change of upper limbs function. Scale ranges from 0 to 57 points for each upper limb. A higher score means a better upper limb function.
Measured: At enrollment and after 7 weeks of the intervention onset
Upper Extremity Motor Score (UEMS)
Change of upper limbs function. Scale ranges from 0 to 50 points if both upper limbs are assessed. A higher score means a better upper limb function.
Measured: At enrollment and after 7 weeks of the intervention onset
Capabilities of Upper Extremities Questionnaire (CUE-Q)
Change of the functional limitation in tetraplegia. Scale ranges from 32 to 224 points if both upper limbs are assessed. A higher score means less functional limitation outcome.
Measured: At enrollment and after 7 weeks of the intervention onset
Secondary outcomes (2)
Spinal Cord Independence Measure III (SCIM-III)
Change of achievements of daily function. Scale ranges from 0 to 100 points. A higher score means a better capacity to perform activities of the daily living.
Measured: At enrollment and after 7 weeks of the intervention onset
Life Satisfaction Questionnaire 9 (LISAT-9)
Change of life satisfaction. Scale ranges from 0 to 54 points. A higher score is expected with a better life satisfaction.
Measured: At enrollment and after 7 weeks of 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 posted25 Apr 2022
- Study start1 Aug 2022
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Collaborators
- Instituto Tecnologico y de Estudios Superiores de Monterey
- 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
- NCT05343130
- Sponsor's protocol ID
- 10/22
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2022
- Last updated
- 25 Jun 2025
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Therapy With Brain-Computer Interface Controlled Functional Electrical Stimulation for Neurorehabilitation of Patients With Spinal Cord Injury (Eficacia de Una Terapia Con estimulación eléctrica Funcional Controlada Con Interfaz Cerebro-computadora Para neurorrehabilitación de Pacientes Con lesión Medular)
- ClinicalTrials.gov ID
- NCT05343130
- Acronym / sponsor ID
- 10/22
- Conditions
- Cervical Spinal Cord Injury
- Keywords
- brain-computer interface, functional electrical stimulation, motor rehabilitation, tetraplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Collaborators
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Apr 2022 (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 the efficacy of a therapy with brain-computer interface controlled functional electrical stimulation for neurorehabilitation of spinal cord injury patients' upper limbs. For this purpose, a randomized controlled trial will be performed to compare the clinical and physiological effects of the brain-computer interface therapy with those of a sham intervention comprised by the application of functional electrical stimulation independently of brain-computer interface control.
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 functional electrical stimulation feedback | Experimental | Device: Brain-Computer Interface |
| Sham Brain-Computer Interface controlled functional electrical stimulation 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)
- Spinal Cord Injury at neurological levels C6 or C7
- American Spinal Injury Association (ASIA) classification A, B, C or D
- Upper limb spasticity of less or equal to +1 measured with the Modified Ashworth Scale
- Time since disease onset of more than 6 months and less than 60 months
- Normal or corrected to normal vision
Key exclusion criteria (9 listed)
- Severe attention deficits
- Previous diagnosis of traumatic brain injury
- Previous diagnosis of peripheral nerve injury
- Previous stroke diagnosis
- Previous diagnosis of neurodegenerative diseases
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 InterfaceHand movement will be elicited using functional electrical stimulation activated by the brain-computer interface based on hand movement intention. | Device | Brain-Computer Interface controlled functional electrical stimulation feedback |
| Sham Brain-Computer InterfaceHand movement will be elicited using functional electrical stimulation which activation will be independent of the brain-computer interface based on hand movement intention. | Device | Sham Brain-Computer Interface controlled functional electrical stimulation feedback |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: At enrollment and after 7 weeks of the intervention onset
Change of upper limbs function. Scale ranges from 0 to 57 points for each upper limb. A higher score means a better upper limb function.
Upper Extremity Motor Score (UEMS)
Time frame: At enrollment and after 7 weeks of the intervention onset
Change of upper limbs function. Scale ranges from 0 to 50 points if both upper limbs are assessed. A higher score means a better upper limb function.
Capabilities of Upper Extremities Questionnaire (CUE-Q)
Time frame: At enrollment and after 7 weeks of the intervention onset
Change of the functional limitation in tetraplegia. Scale ranges from 32 to 224 points if both upper limbs are assessed. A higher score means less functional limitation outcome.
2 secondary outcomes
Spinal Cord Independence Measure III (SCIM-III)
Time frame: At enrollment and after 7 weeks of the intervention onset
Life Satisfaction Questionnaire 9 (LISAT-9)
Time frame: At enrollment and after 7 weeks of the intervention onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- 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
Related trials for Cervical Spinal Cord Injury
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
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Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
Spinal Cord Injuries, Cervical Spinal Cord Injury
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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Active, not recruitingPhase 1/2
Effect of Rimonabant on Hand Function in Patients With Spinal Cord Injury
Cervical Spinal Cord Injury
Not yet recruiting
Transcutaneous Spinal Cord Stimulation for Blood Pressure Augmentation Immediately After Spinal Cord Injury
Spinal Cord Injury Cervical, Spinal Cord Injuries (SCI)
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.
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 Cervical Spinal Cord Injury, 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 9 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: looking for participants now, as of the sponsor's last update on 25 Jun 2025. 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?
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?
Contact Jessica Cantillo-Negrete, PhD (+525559991000 ext. 19008, jcantillo@inr.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: At enrollment and after 7 weeks of the intervention onset). The study lists 3 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 25 Jun 2025; AzTrials last refreshed its copy on 27 Oct 2026.