Spinal Cord InjuriesNCT04727866
Brain Plus Spinal Stimulation for Cervical SCI
A study testing transcutaneous spinal direct current stimulation (tsDCS) - coronal, transcutaneous spinal direct current stimulation (tsDCS) - caudal and transcutaneous spinal direct current stimulation (tsDCS) - rostral in people with Spinal Cord Injuries and Spinal Cord Injury at C5-C7 Level, run by Bronx VA Medical Center at 1 site in United States.
Trial summary
The goal of this project is to strengthen residual corticospinal tract (CST) connections after partial injury using combined motor cortex and spinal cord stimulation to improve arm and hand function after spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Injury at C5-C7 Level, Tetraplegia/Tetraparesis
- What is being tested?
- transcutaneous spinal direct current stimulation (tsDCS) - coronal, transcutaneous spinal direct current stimulation (tsDCS) - caudal and transcutaneous spinal direct current stimulation (tsDCS) - rostral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 13 Jan 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able-bodied participants
- Age between 18 and 75 years;
- No known central or peripheral neurological disease or injury.
- SCI participants
- Age between 18 and 75 years;
- Chronic (> 12 months) SCI between neurological levels C1-C8;
- Score of 2, 3, or 4 (out of 5) on manual muscle testing of elbow flexion, wrist extension, wrist flexion, finger extension, finger flexion, or finger abduction in left or right hand;
Who cannot join
- Multiple spinal cord lesions;
- History of seizures;
- Ventilator dependence or patent tracheostomy site;
- Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, or brain abscess;
- History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);
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- History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic metallic implants, or cardiac pacemaker/defibrillator;
- Significant coronary artery or cardiac conduction disease;
- Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);
- History of bipolar disorder;
- History of suicide attempt;
- Active psychosis;
- Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) within previous 48 hours;
- Open skin lesions over the face, neck, shoulders, or arms;
- Pregnancy;
- Unsuitable for study participation as determined by study physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters Veterans Affairs Medical Center
The Bronx, New York, 10468
About this study
Official title: Motor Cortex Plus Spinal Cord Stimulation for Chronic Cervical Spinal Cord Injury
The goal of this project is to strengthen residual corticospinal tract (CST) connections after partial injury using combined motor cortex and spinal cord stimulation to improve arm and hand function after spinal cord injury (SCI).
To do this, the investigators will test the combination of transcranial magnetic stimulation (TMS) with transcutaneous spinal direct current stimulation (tsDCS) in individuals with chronic cervical SCI.
Read the detailed description
For people with cervical SCI, regaining hand function is their highest priority. Most SCIs are motor incomplete, and even when complete, there is often significant amounts of spared spinal cord white matter. The goal of this project is to strengthen residual corticospinal tract (CST) connections after partial injury using combined motor cortex and spinal cord stimulation to improve arm and hand function.
The team's research in rats, which has been refined in over a decade of study, demonstrates that brain and spinal cord stimulation fully restores motor skills in rats after CST injury. Most significant for the population of people living with SCI, this approach is effective in the chronic phase of injury.
Recently, the investigators translated this electrical stimulation protocol into one that can be rapidly translated into people using non-invasive techniques. In rats, combined electrical intermittent theta burst stimulation (iTBS) of motor cortex with transcutaneous spinal direct current stimulation (tsDCS) activates the cervical spinal cord. This protocol, which is administered only 30 minutes a day for 10 days, causes large-scale sprouting of CST connections and full recovery of forelimb function. Thus, by combining brain and spinal cord electrical stimulation in rodents with corticospinal system injury durable CST axonal sprouting, strengthening of CST connections, and recovery is achieved.
In this proposal, the investigators intend to bring this promising therapeutic approach to humans with cervical SCI. The team will study people with chronic, motor incomplete, SCI to test the safety and feasibility of this approach. The investigators' approach is non-invasive and, if shown to be effective, can be rapidly integrated into current clinical practice to help restore hand function in people with chronic SCI.
Each subject will undergo four stimulation sessions of 4 hours or less. Outcomes focus on safety and neurophysiological transmission. The first session is used to determine the target muscle, optimal scalp site for TMS stimulation, assess cervical tsDCS tolerability, and measure maximal contraction force of the fingers, wrist, and elbow. The second through fourth sessions will assess the acute tolerability and effects of tsDCS with different intensities and electrode configurations in a randomized order. Each session will test a different electrode configuration and will be divided into two stages. The first stage will randomly deliver three 5-minute blocks of tsDCS at different randomized intensities (100%, 66% and 0% (sham) of tolerated intensity, as determined in Session 1) and assess changes in corticospinal and spinal excitability in response to TMS and peripheral nerve stimulation (PNS) of the target muscle. The second stage will assess the acute effects of 20-minutes of tsDCS delivered at two thirds the maximal tolerability on TMS- and PNS-evoked responses and performance of a motor task. Safety and tolerability will be closely monitored at all times.
- Being tested
- transcutaneous spinal direct current stimulation (tsDCS) - coronal, transcutaneous spinal direct current stimulation (tsDCS) - caudal, transcutaneous spinal direct current stimulation (tsDCS) - rostral, intermittent theta burst stimulation (iTBS)
- Keywords
- transcranial magnetic stimulation, spinal direct current stimulation
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous spinal direct current stimulation (tsDCS) - coronalDevice
20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with cathode over C5-C7 transverse process on target side, anode over C5-C7 transverse process on non-target side.
transcutaneous spinal direct current stimulation (tsDCS) - caudalDevice
20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over ~T1-T4 posteriorly, anode over ~C5-T1 anteriorly
transcutaneous spinal direct current stimulation (tsDCS) - rostralDevice
20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over ~C3-C5 posteriorly, anode over ~C5-T1 anteriorly
intermittent theta burst stimulation (iTBS)Device
3 minutes of iTBS (a form of repetitive TMS) will be delivered during a 5-minute interval of DCS
| Study group | Role | What they receive |
|---|---|---|
| Rostral tsDCS | Experimental | DCS cathode over ~C3-C5 posteriorly, anode over ~C5-T1 anteriorly Receives: Device: transcutaneous spinal direct current stimulation (tsDCS) - rostral; Device: intermittent theta burst stimulation (iTBS) |
| Caudal tsDCS | Experimental | DCS cathode over ~T1-T4 posteriorly, anode over ~C5-T1 anteriorly Receives: Device: transcutaneous spinal direct current stimulation (tsDCS) - caudal; Device: intermittent theta burst stimulation (iTBS) |
| Coronal tsDCS | Experimental | DCS cathode over C5-C7 transverse process on target side, anode over C5-C7 transverse process on non-target side. Receives: Device: transcutaneous spinal direct current stimulation (tsDCS) - coronal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potential (MEP) amplitudes
Response to transcranial magnetic stimulation in hand and forearm muscles
Measured: Change immediately after procedure
Secondary outcomes (3)
H-reflex amplitudes
Response to peripheral nerve stimulation in extensor and flexor carpi radialis
Measured: Change immediately after procedure
Muscle dynamometry
Pinch and wrist extension force will be measured using dynamometry
Measured: Change immediately after procedure
Intracortical inhibition and facilitation
Change in MEP amplitude when subthreshold conditioning pulses delivered at varying interstimulus intervals
Measured: Change immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start4 Jan 2021
- Primary completion12 Jan 2024
- Study completion13 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bronx VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- New York State Department of Health
- Responsible party
- Principal investigator, Noam Y. Harel, Bronx VA Medical Center
- Investigators
- Noam Y Harel, MD, PhD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727866
- Sponsor's protocol ID
- HAR-19-57
- Other IDs
- C31291
- Status last verified
- Jan 2024
- First submitted
- 13 Nov 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified, individual-level data will be deposited to appropriate public repositories, such as Open Data Commons for Spinal Cord Injury (https://scicrunch.org/odc-sci), Figshare, or others. This will allow more powerful meta-analysis of disparate smaller studies, a need which is even more urgent in neurorehabilitation than in other fields that are more amenable to large drug studies.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Cortex Plus Spinal Cord Stimulation for Chronic Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04727866
- Acronym / sponsor ID
- HAR-19-57
- Keywords
- transcranial magnetic stimulation, spinal direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bronx VA Medical CenterUS federal agency
- Collaborators
- New York State Department of Health
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 27 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 goal of this project is to strengthen residual corticospinal tract (CST) connections after partial injury using combined motor cortex and spinal cord stimulation to improve arm and hand function after spinal cord injury (SCI).
To do this, the investigators will test the combination of transcranial magnetic stimulation (TMS) with transcutaneous spinal direct current stimulation (tsDCS) in individuals with chronic cervical SCI.
Detailed description
For people with cervical SCI, regaining hand function is their highest priority. Most SCIs are motor incomplete, and even when complete, there is often significant amounts of spared spinal cord white matter. The goal of this project is to strengthen residual corticospinal tract (CST) connections after partial injury using combined motor cortex and spinal cord stimulation to improve arm and hand function.
The team's research in rats, which has been refined in over a decade of study, demonstrates that brain and spinal cord stimulation fully restores motor skills in rats after CST injury. Most significant for the population of people living with SCI, this approach is effective in the chronic phase of injury.
Recently, the investigators translated this electrical stimulation protocol into one that can be rapidly translated into people using non-invasive techniques. In rats, combined electrical intermittent theta burst stimulation (iTBS) of motor cortex with transcutaneous spinal direct current stimulation (tsDCS) activates the cervical spinal cord. This protocol, which is administered only 30 minutes a day for 10 days, causes large-scale sprouting of CST connections and full recovery of forelimb function. Thus, by combining brain and spinal cord electrical stimulation in rodents with corticospinal system injury durable CST axonal sprouting, strengthening of CST connections, and recovery is achieved.
In this proposal, the investigators intend to bring this promising therapeutic approach to humans with cervical SCI. The team will study people with chronic, motor incomplete, SCI to test the safety and feasibility of this approach. The investigators' approach is non-invasive and, if shown to be effective, can be rapidly integrated into current clinical practice to help restore hand function in people with chronic SCI.
Each subject will undergo four stimulation sessions of 4 hours or less. Outcomes focus on safety and neurophysiological transmission. The first session is used to determine the target muscle, optimal scalp site for TMS stimulation, assess cervical tsDCS tolerability, and measure maximal contraction force of the fingers, wrist, and elbow. The second through fourth sessions will assess the acute tolerability and effects of tsDCS with different intensities and electrode configurations in a randomized order. Each session will test a different electrode configuration and will be divided into two stages. The first stage will randomly deliver three 5-minute blocks of tsDCS at different randomized intensities (100%, 66% and 0% (sham) of tolerated intensity, as determined in Session 1) and assess changes in corticospinal and spinal excitability in response to TMS and peripheral nerve stimulation (PNS) of the target muscle. The second stage will assess the acute effects of 20-minutes of tsDCS delivered at two thirds the maximal tolerability on TMS- and PNS-evoked responses and performance of a motor task. Safety and tolerability will be closely monitored at all times.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rostral tsDCS | Experimental | Device: transcutaneous spinal direct current stimulation (tsDCS) - rostral, Device: intermittent theta burst stimulation (iTBS)DCS cathode over ~C3-C5 posteriorly, anode over ~C5-T1 anteriorly |
| Caudal tsDCS | Experimental | Device: transcutaneous spinal direct current stimulation (tsDCS) - caudal, Device: intermittent theta burst stimulation (iTBS)DCS cathode over ~T1-T4 posteriorly, anode over ~C5-T1 anteriorly |
| Coronal tsDCS | Experimental | Device: transcutaneous spinal direct current stimulation (tsDCS) - coronalDCS cathode over C5-C7 transverse process on target side, anode over C5-C7 transverse process on non-target side. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able-bodied participants
- Age between 18 and 75 years;
- No known central or peripheral neurological disease or injury.
- SCI participants
- Age between 18 and 75 years;
Key exclusion criteria (16 listed)
- Multiple spinal cord lesions;
- History of seizures;
- Ventilator dependence or patent tracheostomy site;
- Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion;
- History of stroke, brain tumor, or brain abscess;
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 |
|---|---|---|
| transcutaneous spinal direct current stimulation (tsDCS) - coronal20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with cathode over C5-C7 transverse process on target side, anode over C5-C7 transverse process on non-target side. | Device | Coronal tsDCS |
| transcutaneous spinal direct current stimulation (tsDCS) - caudal20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over ~T1-T4 posteriorly, anode over ~C5-T1 anteriorly | Device | Caudal tsDCS |
| transcutaneous spinal direct current stimulation (tsDCS) - rostral20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over ~C3-C5 posteriorly, anode over ~C5-T1 anteriorly | Device | Rostral tsDCS |
| intermittent theta burst stimulation (iTBS)3 minutes of iTBS (a form of repetitive TMS) will be delivered during a 5-minute interval of DCS | Device | Caudal tsDCS, Rostral tsDCS |
Primary outcome
Motor evoked potential (MEP) amplitudes
Time frame: Change immediately after procedure
Response to transcranial magnetic stimulation in hand and forearm muscles
3 secondary outcomes
H-reflex amplitudes
Time frame: Change immediately after procedure
Muscle dynamometry
Time frame: Change immediately after procedure
Intracortical inhibition and facilitation
Time frame: Change immediately after procedure
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 17 Jan 2024.
- Individual participant dataSharing planned: Yes. Deidentified, individual-level data will be deposited to appropriate public repositories, such as Open Data Commons for Spinal Cord Injury (https://scicrunch.org/odc-sci), Figshare, or others. This will allow more powerful meta-analysis of disparate smaller studies, a need which is even more urgent in neurorehabilitation than in other fields that are more amenable to large drug studies.
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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.
Noam Y Harel, MD, PhD principal investigator
James J. Peters Veterans Affairs 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 transcutaneous spinal direct current stimulation (tsDCS) - coronal, transcutaneous spinal direct current stimulation (tsDCS) - caudal and transcutaneous spinal direct current stimulation (tsDCS) - rostral in people with Spinal Cord Injuries and Spinal Cord Injury at C5-C7 Level, run by Bronx VA 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 7 inclusion and 16 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 17 Jan 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 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?
Motor evoked potential (MEP) amplitudes (time frame: Change immediately after procedure). 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 17 Jan 2024.