Spinal Cord InjuryBMINCT02564419
Brain Machine Interface (BMI) in Subjects Living With Quadriplegia
A study testing Medtronic Activa PC+S in people with Spinal Cord Injury, run by Jonathan Jagid at 1 site in United States.
Trial summary
In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. Read more about this study
- Who is it for?
- Ages 22 to 50 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Medtronic Activa PC+S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 30 Nov 2019
- 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 22 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- AIS Grades A \& B
- Level of Injury C5 or C6
- Local Community dwelling
- Stable chronic injury
- Stable health status and upper extremities
- Completion of Clinical Protocol 01
Who cannot join
- Coagulopathy
- Anticoagulation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami School of Medicine/Miami Project to Cure Paralysis
Miami, Florida, 33136
About this study
Official title: Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury
In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be
- either processed in the Activa PC+S; or
- off-loaded via the Nexus D communication device (Medtronic) to a computer.
- Conditions
- Spinal Cord Injury
- Being tested
- Medtronic Activa PC+S
- 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.
Medtronic Activa PC+SDevice
Upon consent, the good candidates will undergo surgical screening that includes a full neurological workup and baseline functional assessment. Subjects that demonstrate feasibility for control will undergo surgery for unilateral implantation of the Activa PC+S as well as the implantation of unilateral subdural strip electrodes (Resume II, model 3587A) over the motor cortex. After 24 hour observation in the hospital, subjects will participate in 24 distinct sessions or visits of testing over a 3-6 month period. During these visits, the sensing, decoding of the implanted device (Activa PC+S) as well as the external stimulation components (Bioness H200) and parameters will be tested and benchmarked. Subjects will participate for 24 sessions and continue to participate in the study until the end of life of the device, at which point the subject may elect to undergo an explant at that time.
| Study group | Role | What they receive |
|---|---|---|
| Medtronic Activa PC+S | Experimental | Objective of this pilot phase early feasibility study is to assess the safety and feasibility of Medtronic Activa PC+S implant (device) by;
1. Evaluating the ability of the Activa PC+S system to sense ECoG signals in subjects living with quadriplegia (C5 or C6 level).
2. Assessing the feasibility of activating fundamental upper extremity muscles to reproduce hand grasp.
These are important first steps towards creating and designing a device that can enhance or assist in performing activities of daily living (ADL) in the life of these subjects. Attachment 15.3 Receives: Device: Medtronic Activa PC+S |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIS Motor Score
American Spinal Injury Association (ASIA) Impairment Scale (AIS) Motor scores has a score totaling 0-50 for the upper limbs and 0-50 for the lower limbs with the lower score indicating greater motor impairment
Measured: Up to 2 years
AIS Sensory Score
AIS Sensory scores has a score totaling 0-56 points for light touch and pin prick modalities for a total of a maximum of 112 points per side of the body. The lower scores indicate greater sensory impairment.
Measured: Up to 2 years
SF-36 scores
Short Form 36 (SF-36) is a 36 item self-report health questionnaire
Measured: Up to 2 years
Muscle Force Test
- No movement;1.Palpable contraction, no visible movement; 2. Movement but only with gravity eliminated; 3. Movement against gravity; 4. Movement against resistance but weaker than normal; 5. Normal power
Measured: Up to 2 years
Range of Motion
Joint Range of Motion for both active and passive for Flexion and extension
Measured: Up to 2 years
SCIM III (Spinal Cord Independence Measure)
Self-report independence for daily activities of living scored from 1-6
Measured: Up to 2 years
JTT Hand Function Test
Functional timed activities such as hand writing, page turning, lifting small objects, feeding, stacking checkers, lifting light cans and lifting heavy cans
Measured: Up to 2 years
Pinch Grip Strength
Measurement of grip strength throughout training
Measured: Up to 2 years
Modified Ashworth Scale
Muscle tone scored during stretch from 0 to 5
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startNov 2015
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
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 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Medtronic Activa PC + S is a multi-programmable primary cell neurostimulator that records bioelectric data and deliver electrical stimulation through leads implanted in the brain.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Jagid
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Jonathan Jagid, University of Miami
- Investigators
- Jonathan R Jagid, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564419
- Sponsor's protocol ID
- 20150244
- Acronym
- BMI
- Status last verified
- Sep 2020
- First submitted
- 18 Aug 2015
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Davis KC, Wyse-Sookoo KR, Raza F, Meschede-Krasa B, Prins NW, Fisher L, Brown EN, Cajigas I, Ivan ME, Jagid JR, Prasad A. 5-year follow-up of a fully implanted brain-computer interface in a spinal cord injury patient. J Neural Eng. 2025 Apr 8;22(2):10.1088/1741-2552/adc48c. doi: 10.1088/1741-2552/adc48c.
PubMed 40127544Davis KC, Meschede-Krasa B, Cajigas I, Prins NW, Alver C, Gallo S, Bhatia S, Abel JH, Naeem JA, Fisher L, Raza F, Rifai WR, Morrison M, Ivan ME, Brown EN, Jagid JR, Prasad A. Design-development of an at-home modular brain-computer interface (BCI) platform in a case study of cervical spinal cord injury. J Neuroeng Rehabil. 2022 Jun 3;19(1):53. doi: 10.1186/s12984-022-01026-2.
PubMed 35659259
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of a Medtronic Activa PC+S System for Persons Living With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02564419
- Acronym / sponsor ID
- BMI / 20150244
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Jonathan JagidUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2015 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 30 Sep 2015 (estimated)
- 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.
In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be
- either processed in the Activa PC+S; or
- off-loaded via the Nexus D communication device (Medtronic) to a computer.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Medtronic Activa PC + S is a multi-programmable primary cell neurostimulator that records bioelectric data and deliver electrical stimulation through leads implanted in the brain.
| Arm | Type | Receives |
|---|---|---|
| Medtronic Activa PC+S | Experimental | Device: Medtronic Activa PC+SObjective of this pilot phase early feasibility study is to assess the safety and feasibility of Medtronic Activa PC+S implant (device) by; 1. Evaluating the ability of the Activa PC+S system to sense ECoG signals in subjects living with quadriplegia (C5 or C6 level). 2. Assessing the feasibility of activating fundamental upper extremity muscles to reproduce hand grasp. These are important first steps towards creating and designing a device that can enhance or assist in performing activities of daily living (ADL) in the life of these subjects. Attachment 15.3 |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- AIS Grades A \& B
- Level of Injury C5 or C6
- Local Community dwelling
- Stable chronic injury
- Stable health status and upper extremities
Key exclusion criteria (3 listed)
- Coagulopathy
- Anticoagulation
- Pregnancy
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 |
|---|---|---|
| Medtronic Activa PC+SUpon consent, the good candidates will undergo surgical screening that includes a full neurological workup and baseline functional assessment. Subjects that demonstrate feasibility for control will undergo surgery for unilateral implantation of the Activa PC+S as well as the implantation of unilateral subdural strip electrodes (Resume II, model 3587A) over the motor cortex. After 24 hour observation in the hospital, subjects will participate in 24 distinct sessions or visits of testing over a 3-6 month period. During these visits, the sensing, decoding of the implanted device (Activa PC+S) as well as the external stimulation components (Bioness H200) and parameters will be tested and benchmarked. Subjects will participate for 24 sessions and continue to participate in the study until the end of life of the device, at which point the subject may elect to undergo an explant at that time. | Device | Medtronic Activa PC+S |
Primary outcome
AIS Motor Score
Time frame: Up to 2 years
American Spinal Injury Association (ASIA) Impairment Scale (AIS) Motor scores has a score totaling 0-50 for the upper limbs and 0-50 for the lower limbs with the lower score indicating greater motor impairment
AIS Sensory Score
Time frame: Up to 2 years
AIS Sensory scores has a score totaling 0-56 points for light touch and pin prick modalities for a total of a maximum of 112 points per side of the body. The lower scores indicate greater sensory impairment.
SF-36 scores
Time frame: Up to 2 years
Short Form 36 (SF-36) is a 36 item self-report health questionnaire
Muscle Force Test
Time frame: Up to 2 years
0. No movement;1.Palpable contraction, no visible movement; 2. Movement but only with gravity eliminated; 3. Movement against gravity; 4. Movement against resistance but weaker than normal; 5. Normal power
Range of Motion
Time frame: Up to 2 years
Joint Range of Motion for both active and passive for Flexion and extension
SCIM III (Spinal Cord Independence Measure)
Time frame: Up to 2 years
Self-report independence for daily activities of living scored from 1-6
JTT Hand Function Test
Time frame: Up to 2 years
Functional timed activities such as hand writing, page turning, lifting small objects, feeding, stacking checkers, lifting light cans and lifting heavy cans
Pinch Grip Strength
Time frame: Up to 2 years
Measurement of grip strength throughout training
Modified Ashworth Scale
Time frame: Up to 2 years
Muscle tone scored during stretch from 0 to 5
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 18 Sep 2020.
- Derived from this study: PubMed 40127544Davis KC, Wyse-Sookoo KR, Raza F, Meschede-Krasa B, Prins NW, Fisher L, Brown EN, Cajigas I, Ivan ME, Jagid JR, Prasad A. 5-year follow-up of a fully implanted brain-computer interface in a spinal cord injury patient. J Neural Eng. 2025 Apr 8;22(2):10.1088/1741-2552/adc48c. doi: 10.1088/1741-2552/adc48c.
- Derived from this study: PubMed 35659259Davis KC, Meschede-Krasa B, Cajigas I, Prins NW, Alver C, Gallo S, Bhatia S, Abel JH, Naeem JA, Fisher L, Raza F, Rifai WR, Morrison M, Ivan ME, Brown EN, Jagid JR, Prasad A. Design-development of an at-home modular brain-computer interface (BCI) platform in a case study of cervical spinal cord injury. J Neuroeng Rehabil. 2022 Jun 3;19(1):53. doi: 10.1186/s12984-022-01026-2.
- 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. This study is not recruiting at the moment.
Jonathan R Jagid, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Activa PC+S in people with Spinal Cord Injury, run by Jonathan Jagid 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 6 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: finished, as of the sponsor's last update on 18 Sep 2020. 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?
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?
AIS Motor Score (time frame: Up to 2 years). The study lists 9 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 NCT02564419, 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 18 Sep 2020.