Spinal Cord Injury (SCI), Initial EncounterNCT06533969
Assessment of Neural Signals for the Control of Assistive Devices
A study testing Epidural Spinal Cord Stimulation, Electrocorticographic and Electroencephalographic in people with Spinal Cord Injury (SCI), Initial Encounter, run by University of Miami at 2 sites in United States.
Trial summary
The study will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (ESCS) with individuals with SCI. Motor intention of UL tasks will be decoded using brain-computer interface (BCI) system based on cortical signals recorded using an Electroencephalographic (EEG)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury (SCI), Initial Encounter
- What is being tested?
- Epidural Spinal Cord Stimulation, Electrocorticographic and Electroencephalographic
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Sep 2024to 31 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
- Patients age 18 and older
- Able to sign informed consent
- Not participating in other studies that limit participation
- Chronic (>6 month) traumatic Spinal Cord Injury (SCI) (C4-T1 neurological injury with American Spinal Injury Association Impairment Scale (AIS A-D) with some residual function.
Who cannot join
- Patients that are pregnant
- Patients under the age of 18
- Patients unable to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Lynn Rehabilitation Center
Miami, Florida, 33136
Letitia Fisher, 305-243-3056, lfisher@miami.edu
Matija Milosevic, PhD, 3052433572, mxm194475@miami.edu
- Recruiting
The Miami Project to Cure Paralysis
Miami, Florida, 33136
Letitia Fisher, BLA, 3052433056, lfisher@miami.edu
Matija Milosevic, Co-I, PhD, 305-243-3572, mmilosevic@med.miami.edu
About this study
The study will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (ESCS) with individuals with SCI. Motor intention of UL tasks will be decoded using brain-computer interface (BCI) system based on cortical signals recorded using an Electroencephalographic (EEG) system or using their intracranially implanted devices Electrocorticographic (ECoG).
- Being tested
- Epidural Spinal Cord Stimulation, Electrocorticographic, Electroencephalographic
- Keywords
- Brain Computer Interface, Epidural Spinal Cord Stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Spinal Cord StimulationProcedure or surgery
Also called ESCS
This will be a one time surgery lasting no more than 2 hours where ESCS electrodes will be connected to an external stimulator approved for human research. Stimulation intensity and parameters will be configured before each session for optimal upper extremity motor function.
The ESCS approach will include surgical implantation of temporarily placed leads in the cervical epidural space and connection cables tunneled percutaneously through the skin for <30 days
ElectrocorticographicDevice
Also called ECoG
Neural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices.
ElectroencephalographicDevice
Also called EEG
Neural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices.
| Study group | Role | What they receive |
|---|---|---|
| Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS) | Experimental | Participants in this group will receive a onetime surgery to have the leads implanted temporarily for ESCS which will be triggered through the BCI system. The BCI-ESCS arms will include Upper limb (UL) therapist-guided training, with triggered through a BCI system during task practice. The BCI system will decode motor intention of Upper limb (UL) tasks from cortical signals recorded using EEG system or using their intracranially implanted devices (e.g., ECoG). Participants will perform UL daily activities (e.g., grasping, reaching) tailored to participants deficits. The therapist will facilitate task practice and progress therapy within and between session.
Subjects will be involved in the intervention for up to 2 months. Receives: Procedure: Epidural Spinal Cord Stimulation; Device: Electrocorticographic; Device: Electroencephalographic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hand Motor Function
Toronto Rehabilitation Institute Hand Function Test (TRI-HFT): Measured on a scale from 0-133 to assess upper extremity manipulation and grip force at time points before and after implant.
Higher scores indicate better hand motor function.
Measured: Baseline, up to 2 months post-implant
Change in Hand Motor Evoked Potential (MEP)
Change in Motor Evoked Potential (MEP): MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).
Measured: Baseline, up to 2 months post-implant
Secondary outcomes (8)
Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)
Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP): Standardized test to be measured on a scale from 0-116 through the combination of five subset scores to assess grasping ability at time points before and after implant. A composite score will be obtained for strength, muscle force and tasks.
Higher scores indicate better hand motor function.
Measured: Baseline, up to 2 months post-implant
Change in Muscle Coordination Measured by Electromyography (EMG)
Functional tasks: Assessments to measure reaching ability and obtain muscle coordination via EMG (millivolts).
Measured: Baseline, up to 2 months post-implant
Change in Movement Kinematics
Kinematics data (motion capture, measured in centimeters) at time points before and after implant.
Measured: Baseline, up to 2 months post-implant
Change in Muscle Strength
Muscle force testing: Assessment of changes in muscle strength from measured in Newtons at time points before and after implant.
Measured: Baseline, up to 2 months post-implant
Change in Quality of Life
Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL): ISCI-QOL consists of three single items on satisfaction with life as a whole, physical health, and psychological health using a 0-10 scale where 0=complete dissatisfaction; 10=complete satisfaction.
A composite score will be obtained for this measure.
Measured: Baseline, up to 2 months post-implant
Change in Independence Measured by Spinal Cord Independence Measure (SCIM III)
Independence as measured by Spinal Cord Independence Measure (SCIM III): SCIM III assesses performance in activities of daily living Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.
Measured: Baseline, up to 2 months post-implant
Change in Satisfaction of Life
Medical Outcomes Study Short Form 36 (SF-36): Patient-reported outcome measurement for health-related quality of life and activities of daily living scored on a scale of 0 (negative health) to 100 (positive health).
Measured: Baseline, up to 2 months post-implant
Change in Pain Levels
Brief Pain Inventory (BPI): A questionnaire for pain will be assessed on a scale of 0 ("no pain") to 10 ("worst imaginable pain") at different points before and after the implant.
Measured: Baseline, up to 2 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start6 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury (SCI), Initial EncounterStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Jagid, University of Miami
- Investigators
- Jonathan R Jagid, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533969
- Sponsor's protocol ID
- 20190536
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neural Signals for the Control of Assistive Devices
- ClinicalTrials.gov ID
- NCT06533969
- Acronym / sponsor ID
- 20190536
- Keywords
- Brain Computer Interface, Epidural Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Aug 2024 (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 will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (ESCS) with individuals with SCI. Motor intention of UL tasks will be decoded using brain-computer interface (BCI) system based on cortical signals recorded using an Electroencephalographic (EEG) system or using their intracranially implanted devices Electrocorticographic (ECoG).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS) | Experimental | Procedure: Epidural Spinal Cord Stimulation, Device: Electrocorticographic, Device: ElectroencephalographicParticipants in this group will receive a onetime surgery to have the leads implanted temporarily for ESCS which will be triggered through the BCI system. The BCI-ESCS arms will include Upper limb (UL) therapist-guided training, with triggered through a BCI system during task practice. The BCI system will decode motor intention of Upper limb (UL) tasks from cortical signals recorded using EEG system or using their intracranially implanted devices (e.g., ECoG). Participants will perform UL daily activities (e.g., grasping, reaching) tailored to participants deficits. The therapist will facilitate task practice and progress therapy within and between session. Subjects will be involved in the intervention for up to 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age 18 and older
- Able to sign informed consent
- Not participating in other studies that limit participation
- Chronic (>6 month) traumatic Spinal Cord Injury (SCI) (C4-T1 neurological injury with American Spinal Injury Association Impairment Scale (AIS A-D) with some residual function.
Key exclusion criteria (3 listed)
- Patients that are pregnant
- Patients under the age of 18
- Patients unable to provide informed consent
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 |
|---|---|---|
| Epidural Spinal Cord StimulationAlso: ESCSThis will be a one time surgery lasting no more than 2 hours where ESCS electrodes will be connected to an external stimulator approved for human research. Stimulation intensity and parameters will be configured before each session for optimal upper extremity motor function. The ESCS approach will include surgical implantation of temporarily placed leads in the cervical epidural space and connection cables tunneled percutaneously through the skin for <30 days | Procedure or surgery | Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS) |
| ElectrocorticographicAlso: ECoGNeural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices. | Device | Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS) |
| ElectroencephalographicAlso: EEGNeural activity during upper and/or lower extremity tasks will be recorded to characterize the changes that occur in the signals before, during, and after task performance. Observed characteristics of neural signals that are related to the initiation, continuation, or termination of movement will be used to derive control signals that can trigger or enable assistive devices. | Device | Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS) |
Primary outcome
Change in Hand Motor Function
Time frame: Baseline, up to 2 months post-implant
Toronto Rehabilitation Institute Hand Function Test (TRI-HFT): Measured on a scale from 0-133 to assess upper extremity manipulation and grip force at time points before and after implant. Higher scores indicate better hand motor function.
Change in Hand Motor Evoked Potential (MEP)
Time frame: Baseline, up to 2 months post-implant
Change in Motor Evoked Potential (MEP): MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).
8 secondary outcomes
Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)
Time frame: Baseline, up to 2 months post-implant
Change in Muscle Coordination Measured by Electromyography (EMG)
Time frame: Baseline, up to 2 months post-implant
Change in Movement Kinematics
Time frame: Baseline, up to 2 months post-implant
Change in Muscle Strength
Time frame: Baseline, up to 2 months post-implant
Change in Quality of Life
Time frame: Baseline, up to 2 months post-implant
Change in Independence Measured by Spinal Cord Independence Measure (SCIM III)
Time frame: Baseline, up to 2 months post-implant
Change in Satisfaction of Life
Time frame: Baseline, up to 2 months post-implant
Change in Pain Levels
Time frame: Baseline, up to 2 months post-implant
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 26 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injury (SCI), Initial Encounter
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Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury II (PROMPT-SCI II) Trial
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Not yet recruiting
Transcutaneous Spinal Cord Stimulation for Blood Pressure Augmentation Immediately After Spinal Cord Injury
Spinal Cord Injury Cervical, Spinal Cord Injuries (SCI)
Enrolling by invitation
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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.
Jonathan R Jagid, MD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Spinal Cord Stimulation, Electrocorticographic and Electroencephalographic in people with Spinal Cord Injury (SCI), Initial Encounter, run by University of Miami at 2 sites in United States.
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 4 inclusion and 3 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 26 Aug 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 United States. 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?
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 Letitia Fisher (305-243-3056, lfisher@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hand Motor Function (time frame: Baseline, up to 2 months post-implant). 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?
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 26 Aug 2026.