TetraplegiaReHABNCT03898804
An Early Feasibility Study of the ReHAB System
A study testing BCI and FES in people with Tetraplegia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to examine the feasibility of a system that involves implanting small electrodes in the parts of the brain that control movement and sensation, and combining that with electrodes in the upper arm and shoulder to activate paralyzed muscles of the arm and hand. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Tetraplegia
- What is being tested?
- BCI and FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 1 Aug 2029
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 22 and 65 years of age.
- Tetraplegia due to a static identified disease process (spinal cord injury or stroke) that prevents functional activity of the upper extremity.
- Onset of tetraplegia at least 12 months prior to enrollment, with stability of weakness for at least 3 months.
- Must have sufficiently intact cortical motor structures and stable medical prognoses to be able to perform the BCI control tasks for at least one year. .
- Ability to speak understandably or, if unable to speak understandably, a reliable means of yes/no communication.
- Life expectancy greater than 13 months.
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- Chronic care environment within a three-hour drive of the study site or the ability to temporarily relocate to a residence within a three-hour drive of the study site.
- Willingness to remain available (geographically stable) for at least 13 months after enrollment, including maintenance of the evaluation schedule, frequent visits to the Investigator's office, and visits of Sponsor personnel to the subject's chronic care environment.
- Willingness to allow videotape recordings to be made of the surgical procedure (for training purposes) and portions of the Feasibility Evaluations.
- A stable psychosocial support system.
- Scalp devoid of any lesions or skin breakdown precluding surgery.
- Ability to provide voluntarily informed consent in accordance with Site institutional policies and willingness to release of Personal Health Information from the date of the injury or disease onset through the completion of the clinical Study.
- Availability of caregivers capable of providing the necessary daily care of the subject's skin and electrode externalization sites.
Who cannot join
- Presence of an implanted stimulator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator, vagus nerve stimulator, or defibrillator. (Implanted intrathecal pumps for pain or spasticity, cough implants, or diaphragmatic pacers are not excluded.)
- Any active infection(s) or unexplained fever.
- Active cancer within the one year prior to enrollment (other than adequately treated basal or squamous cell skin cancer).
- Uncontrolled insulin-dependent diabetes mellitus.
- Hydrocephalus requiring diversion of cerebrospinal fluid.
- Autonomic dysreflexia within three months prior to enrollment that required urgent evaluation and pharmacologic intervention prescribed by a physician.
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- Seizure within 3 months prior to enrollment.
- Any medical condition expected to require routine MRI imaging or subjects with contraindication(s) to MRI.
- History of osteomyelitis or skin disorder that causes excessive skin sloughing, lesions or breakdown of the scalp.
- Chronic use of medications such as sedatives that may significantly retard motor coordination and cognitive ability.
- Chronic use of anticoagulant medications. (Subjects receiving prophylactic anticoagulation solely for the prevention of deep venous thrombosis are not excluded, but must be able to have their prophylactic anticoagulation suspended temporarily for the surgical procedure and immediate post-operative period.)
- Chronic use of steroids or immunosuppressant therapy.
- Active treatment for another serious medical, neurological or psychiatric disease or disorder that could seriously affect the subject's ability to undergo surgical implantation of the electrodes or participate in the testing sessions.
- Pregnant, lactating, or of childbearing age and not using adequate birth control.
- Active consumption of more than 1 alcoholic beverage per day.
- Suicide attempt within 12 months prior to enrollment.
- History of myocardial infarction or unstable cardiac arrhythmia.
- Enrollment in any other investigational study that may interfere with the time commitments required of this study.
- Subjects who are immunocompromised.
- Subjects who require ongoing diathermy or ultrasound treatments.
- Subjects with severe upper extremity joint contractures or Ashworth spasticity scores of 4 that would limit functional movements.
- Subjects who have contraindication(s) to CT.
- Subjects who are ventilator dependent. Subjects who are sometimes ventilator-assisted (for example, while sleeping) are not excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Jennifer Sweet, MD, 216-844-8522, Jennifer.Sweet@UHhospitals.org
Mario Becerra, RN, 216-844-1734, Mario.Becerra@UHhospitals.org
About this study
Official title: An Early Feasibility Study to Assess the Effects of the "Reconnecting the Hand and Arm to the Brain (ReHAB)" System
The purpose of this research study is to examine the feasibility of a system that involves implanting small electrodes in the parts of the brain that control movement and sensation, and combining that with electrodes in the upper arm and shoulder to activate paralyzed muscles of the arm and hand. This system is intended for people with extensive paralysis in their arms. The small electrodes in the brain will be used to attempt to measure intended movements, and the muscles in the arm and hand will be stimulated to attempt to follow those intentions.
The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study.
Read the detailed description
The overall purpose of this trial is to advance development of a novel technological approach to allow individuals with tetraplegia to interact with their environment using their own paralyzed limbs by combining recording of brain activity, brain stimulation to provide sensory feedback, and stimulation of the paralyzed extremities based on neural recordings.
Device Name:
Reconnecting the Hand and Arm to the Brain (ReHAB) System
Intended Use The proposed device is intended to allow greater functional independence for individuals who are paralyzed due to disease or injury. The purpose of this trial is to advance development of a novel technological approach to allow individuals with tetraplegia to interact with their environment using their own paralyzed limbs by combining recording of brain activity, brain stimulation to provide sensory feedback, and stimulation of the paralyzed extremities based on neural recordings.
The target population are individuals with high tetraplegia, defined as less than antigravity weakness of both upper extremities and both lower extremities as a result of an identified and static (stable for at least 3 months) injury or disease affecting upper motor neurons process that prevents motor neural activity from activating muscles below the neck to perform functional activities. Injuries and diseases that lead to this clinical condition include spinal cord injury, and stroke.
Objective(s):
The primary objective of this study is to evaluate the safety, tolerability, and potential efficacy of an approach combining multiple intracortical brain recording/stimulating microarrays with direct peripheral nerve and muscle stimulation for restoration of arm and hand movement in people with high tetraplegia.
Secondary objectives include validation of the combined platform described above as a clinical device to allow paralyzed individuals to have a more meaningful interaction with their environment as assessed by ability to perform brain-controlled reaching and grasping tasks that ultimately might allow for greater functional independence.
- Conditions
- Tetraplegia
- Being tested
- BCI and FES
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI and FESDevice
The intervention consists of surgical implantation of the device components, BCI and FES that will interface with computers that process and decode neural information, compute stimulation parameters, and control communication between the device components. The device will be tested during research sessions spanning a 13-month period.
| Study group | Role | What they receive |
|---|---|---|
| BCI and FES | Experimental | Surgical implantation of the device and testing for 13 months with an optional 5 year extension study. Receives: Device: BCI and FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events
Successful implantation of brain and extremity recording/stimulating electrodes for 1 year without explantation or device-related serious adverse events.
Measured: 13 months
Secondary outcomes (3)
Success rate of target acquisition of a cursor on a computer screen controlled by neural signals, using a standard center-out-center random target display.
The participant will control the position of a cursor on a monitor using the recorded neural signals and attempt to move the cursor to the target.
Measured: 13 months
Change in number of tasks performed as measured by the ADL Abilities Test.
The participant will control the stimulated movement of their arm and hand using the recorded neural signals. The participant will demonstrate the ability to perform some of the activities of daily living (ADLs) that are part of the ADL Abilities Test.
Measured: 13 months
Change in number of objects successfully grasped and moved during a timed session, as measured by the Grasp Release Test.
The participant will control the stimulated movement of their arm and hand using the recorded neural signals. The participant will demonstrate the ability to grasp and move a series of objects that are part of the Grasp Release Test.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start9 Apr 2019
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study for an additional 5 years, for a total of up to 73 months.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Sweet, M.D., Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898804
- Sponsor's protocol ID
- STUDY20190226
- Acronym
- ReHAB
- Status last verified
- Aug 2026
- First submitted
- 15 Nov 2018
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Herring EZ, Graczyk EL, Memberg WD, Adams RD, Baca-Vaca GF, Hutchison BC, Krall JT, Alexander BJ, Conlan EC, Alfaro KE, Bhat PR, Ketting-Olivier AB, Haddix CA, Taylor DM, Tyler DJ, Kirsch RF, Ajiboye AB, Miller JP. Reconnecting the Hand and Arm to the Brain: Efficacy of Neural Interfaces for Sensorimotor Restoration after Tetraplegia. medRxiv [Preprint]. 2023 Apr 26:2023.04.24.23288977. doi: 10.1101/2023.04.24.23288977.
PubMed 37162904Jakes RS, Alexander BJ, Marcu V, Ajiboye AB, Tyler DJ. A methodological framework for the efficient characterization of peripheral nerve stimulation parameters. J Neural Eng. 2025 Oct 27;22(5):056041. doi: 10.1088/1741-2552/ae0d31.
PubMed 41022103Jakes RS, Alexander BJ, Marcu VI, Ajiboye AB, Tyler DJ. A Methodological Framework for the Efficient Characterization of Peripheral Nerve Stimulation Parameters. medRxiv [Preprint]. 2025 May 23:2025.03.29.25324704. doi: 10.1101/2025.03.29.25324704.
PubMed 40661284Herring EZ, Graczyk EL, Memberg WD, Adams R, Fernandez Baca-Vaca G, Hutchison BC, Krall JT, Alexander BJ, Conlan EC, Alfaro KE, Bhat P, Ketting-Olivier AB, Haddix CA, Taylor DM, Tyler DJ, Sweet JA, Kirsch RF, Ajiboye AB, Miller JP. Reconnecting the Hand and Arm to the Brain: Efficacy of Neural Interfaces for Sensorimotor Restoration After Tetraplegia. Neurosurgery. 2024 Apr 1;94(4):864-874. doi: 10.1227/neu.0000000000002769. Epub 2023 Nov 20.
PubMed 37982637
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Study to Assess the Effects of the "Reconnecting the Hand and Arm to the Brain (ReHAB)" System
- ClinicalTrials.gov ID
- NCT03898804
- Acronym / sponsor ID
- ReHAB / STUDY20190226
- Conditions
- Tetraplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 2 Apr 2019 (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 purpose of this research study is to examine the feasibility of a system that involves implanting small electrodes in the parts of the brain that control movement and sensation, and combining that with electrodes in the upper arm and shoulder to activate paralyzed muscles of the arm and hand. This system is intended for people with extensive paralysis in their arms. The small electrodes in the brain will be used to attempt to measure intended movements, and the muscles in the arm and hand will be stimulated to attempt to follow those intentions.
The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study.
Detailed description
The overall purpose of this trial is to advance development of a novel technological approach to allow individuals with tetraplegia to interact with their environment using their own paralyzed limbs by combining recording of brain activity, brain stimulation to provide sensory feedback, and stimulation of the paralyzed extremities based on neural recordings.
Device Name:
Reconnecting the Hand and Arm to the Brain (ReHAB) System
Intended Use The proposed device is intended to allow greater functional independence for individuals who are paralyzed due to disease or injury. The purpose of this trial is to advance development of a novel technological approach to allow individuals with tetraplegia to interact with their environment using their own paralyzed limbs by combining recording of brain activity, brain stimulation to provide sensory feedback, and stimulation of the paralyzed extremities based on neural recordings.
The target population are individuals with high tetraplegia, defined as less than antigravity weakness of both upper extremities and both lower extremities as a result of an identified and static (stable for at least 3 months) injury or disease affecting upper motor neurons process that prevents motor neural activity from activating muscles below the neck to perform functional activities. Injuries and diseases that lead to this clinical condition include spinal cord injury, and stroke.
Objective(s):
The primary objective of this study is to evaluate the safety, tolerability, and potential efficacy of an approach combining multiple intracortical brain recording/stimulating microarrays with direct peripheral nerve and muscle stimulation for restoration of arm and hand movement in people with high tetraplegia.
Secondary objectives include validation of the combined platform described above as a clinical device to allow paralyzed individuals to have a more meaningful interaction with their environment as assessed by ability to perform brain-controlled reaching and grasping tasks that ultimately might allow for greater functional independence.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study for an additional 5 years, for a total of up to 73 months.
| Arm | Type | Receives |
|---|---|---|
| BCI and FES | Experimental | Device: BCI and FESSurgical implantation of the device and testing for 13 months with an optional 5 year extension study. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age between 22 and 65 years of age.
- Tetraplegia due to a static identified disease process (spinal cord injury or stroke) that prevents functional activity of the upper extremity.
- Onset of tetraplegia at least 12 months prior to enrollment, with stability of weakness for at least 3 months.
- Must have sufficiently intact cortical motor structures and stable medical prognoses to be able to perform the BCI control tasks for at least one year. .
- Ability to speak understandably or, if unable to speak understandably, a reliable means of yes/no communication.
Key exclusion criteria (23 listed)
- Presence of an implanted stimulator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator, vagus nerve stimulator, or defibrillator. (Implanted intrathecal pumps for pain or spasticity, cough implants, or diaphragmatic pacers are not excluded.)
- Any active infection(s) or unexplained fever.
- Active cancer within the one year prior to enrollment (other than adequately treated basal or squamous cell skin cancer).
- Uncontrolled insulin-dependent diabetes mellitus.
- Hydrocephalus requiring diversion of cerebrospinal fluid.
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 |
|---|---|---|
| BCI and FESThe intervention consists of surgical implantation of the device components, BCI and FES that will interface with computers that process and decode neural information, compute stimulation parameters, and control communication between the device components. The device will be tested during research sessions spanning a 13-month period. | Device | BCI and FES |
Primary outcome
Incidence of treatment-related adverse events
Time frame: 13 months
Successful implantation of brain and extremity recording/stimulating electrodes for 1 year without explantation or device-related serious adverse events.
3 secondary outcomes
Success rate of target acquisition of a cursor on a computer screen controlled by neural signals, using a standard center-out-center random target display.
Time frame: 13 months
Change in number of tasks performed as measured by the ADL Abilities Test.
Time frame: 13 months
Change in number of objects successfully grasped and moved during a timed session, as measured by the Grasp Release Test.
Time frame: 13 months
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 20 Aug 2026.
- Results publication: PubMed 37162904Herring EZ, Graczyk EL, Memberg WD, Adams RD, Baca-Vaca GF, Hutchison BC, Krall JT, Alexander BJ, Conlan EC, Alfaro KE, Bhat PR, Ketting-Olivier AB, Haddix CA, Taylor DM, Tyler DJ, Kirsch RF, Ajiboye AB, Miller JP. Reconnecting the Hand and Arm to the Brain: Efficacy of Neural Interfaces for Sensorimotor Restoration after Tetraplegia. medRxiv [Preprint]. 2023 Apr 26:2023.04.24.23288977. doi: 10.1101/2023.04.24.23288977.
- Derived from this study: PubMed 41022103Jakes RS, Alexander BJ, Marcu V, Ajiboye AB, Tyler DJ. A methodological framework for the efficient characterization of peripheral nerve stimulation parameters. J Neural Eng. 2025 Oct 27;22(5):056041. doi: 10.1088/1741-2552/ae0d31.
- Derived from this study: PubMed 40661284Jakes RS, Alexander BJ, Marcu VI, Ajiboye AB, Tyler DJ. A Methodological Framework for the Efficient Characterization of Peripheral Nerve Stimulation Parameters. medRxiv [Preprint]. 2025 May 23:2025.03.29.25324704. doi: 10.1101/2025.03.29.25324704.
- Derived from this study: PubMed 37982637Herring EZ, Graczyk EL, Memberg WD, Adams R, Fernandez Baca-Vaca G, Hutchison BC, Krall JT, Alexander BJ, Conlan EC, Alfaro KE, Bhat P, Ketting-Olivier AB, Haddix CA, Taylor DM, Tyler DJ, Sweet JA, Kirsch RF, Ajiboye AB, Miller JP. Reconnecting the Hand and Arm to the Brain: Efficacy of Neural Interfaces for Sensorimotor Restoration After Tetraplegia. Neurosurgery. 2024 Apr 1;94(4):864-874. doi: 10.1227/neu.0000000000002769. Epub 2023 Nov 20.
- This website provides information about the ReHAB Study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jennifer Sweet, M.D. principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI and FES in people with Tetraplegia, run by University Hospitals Cleveland Medical Center at 1 site 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 13 inclusion and 23 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 20 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 1 site 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 Jennifer Sweet, M.D. ((216) 844-8522, jennifer.sweet@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events (time frame: 13 months). 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 NCT03898804, which also lists 4 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 20 Aug 2026.