Traumatic Spinal Cord InjuryNIBS-SCI1NCT06247904
NIBS Therapy in Subacute Spinal Cord Injury
A study testing Active rTMS in people with Traumatic Spinal Cord Injury and Tetraplegia/Tetraparesis, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
No accepted clinical therapies exist for repair of motor pathways following spinal cord injury (SCI) in humans, leaving permanent disability and devastating personal and socioeconomic cost. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Spinal Cord Injury, Tetraplegia/Tetraparesis
- What is being tested?
- Active rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2025to 31 May 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post traumatic or non-traumatic cervical spinal cord injury (SCI) with residual upper-extremity paralysis
- Time post-injury less than six weeks
- Neurological Level of Injury (NLI) C4-C6
- ASIA Impairment Scale (AIS) A-D
- Sensory and motor zone of partial preservation (ZPP, clinically complete or incomplete)
- Age 18 to 80 years old
Who cannot join
- Ventilator dependence;
- Concurrent neurological condition affecting sensory or motor pathways or otherwise limiting ability to participate in the study;
- Evidence of trauma-related brain injury;
- Contraindications for TMS or history of seizure or seizure risk;
- Spinal instability;
- Uncontrolled autonomic dysreflexia;
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- Severe muscular or skeletal or neuropathic pain;
- Known or suspected pregnancy;
- Medically unstable or any reason the physician may deem as inappropriate for the participant to enroll or continue in the study.
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
Jefferson Moss-Magee Rehabilitation - Elkins Park
Elkins Park, Pennsylvania, 19027
About this study
Official title: Noninvasive Brain Stimulation Therapy in Subacute Human Spinal Cord Injury: A Translational Study
No accepted clinical therapies exist for repair of motor pathways following spinal cord injury (SCI) in humans, leaving permanent disability and devastating personal and socioeconomic cost. A robust neural repair strategy has been demonstrated in preclinical studies, that is ready for translation to recovery of hand and arm function in human SCI, comprising daily transcranial magnetic stimulation treatment at the inpatient rehabilitation facility. This study will establish clinical effect size of the intervention, as well as safety and feasibility necessary for a subsequent controlled efficacy trial and inform preclinical studies for dosing optimization.
Read the detailed description
The objective of this proposal is to begin translating findings from pre-clinical studies to human motor deficits following cervical SCI (cervSCI). This HF-rTMS treatment protocol has not been previously assessed in human SCI and is qualitatively different from rTMS protocols reported to transiently modulate excitability of existing pathways, previously demonstrated in the literature. The protocol involves a daily stimulation of ~10 mins bilateral HF-rTMS for 2 weeks. SCI participants will be studied in a United States inpatient setting for this phase I study.
Given the findings in the pre-clinical model of robust axonal sprouting and functional synapse formation close to the damaged tissue using the above stimulation parameters, the transcranial magnetic stimulation treatment will target the hand-forearm region of the primary motor cortex, bilaterally. The aim is to include the cortical representation of affected muscles adjacent to the neurological level of injury. This zone often contains a mix of clinically and neurophysiologically intact, weakly innervated and denervated corticospinal pathways. Under standard sub-acute rehabilitation care, recovery of up to 1 neurological level of injury (NLI) is often the case, but improvement of 2 or more levels is far less common (<30% of patients). To examine the feasibility and safety of this novel intervention is the principal aim of the study. The associated potential clinical and neurophysiological changes will also be evaluated. These preliminary data will be used to power a subsequent efficacy trial to test the hypothesis that rTMS induced corticospinal augmentation will result in greater than typical extension of the NLI in human SCI, assessed up to the stable recovery phase at 6 months post-injury.
- Being tested
- Active rTMS, sham rTMS
- Keywords
- Spinal cord injury, Cervical spinal cord, Transcranial Magnetic Stimulation, Recovery, Motor cortex
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
Also called active repetitive transcranial magnetic stimulation
The stimulation protocol will comprise 15Hz pulse trains, each 50 pulses, repeated 10x, with a 60s inter-train interval. Stimulation intensity will be determined from individual MRI-modeled e-field, to achieve approximately motor threshold in the target area.
sham rTMSDevice
Also called sham repetitive transcranial magnetic stimulation
The stimulation protocol will comprise 15Hz pulse trains, each 50 pulses, repeated 10x, with a 60s inter-train interval. Stimulation intensity will be close to zero (negligible) since sham coil will be used for the intervention
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | 10 daily sessions of High-frequency Transcranial Magnetic Stimulation (HF-rTMS) applied bilaterally over the hand primary motor area informed by e-field modelling and targeting will be aided by neuronavigation system for precise targeting during each intervention session. Active group will receive HF-rTMS intensity calculated using electric field modelling to create electric field intensity of approximately motor threshold, using the cool-B65 A/P rTMS coil. Receives: Device: Active rTMS |
| Sham rTMS | Sham comparator | 10 daily sessions of Sham High-frequency Transcranial Magnetic Stimulation (HF-rTMS) applied bilaterally over the hand primary motor area informed by e-field modelling and targeting will be aided by neuronavigational system for precise targeting during each intervention session Sham group receives no active magnetic stimulation. Cool-B65 A/P rTMS coil will be used to avoid unblinding of administrator and/or study participant. Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility - (Percentage candidates eligible of screened patients)
The proportion of patients who can take part in the study, whether they later agree to or not.
Measured: 21 months (Recruitment period)
Recruitment - (Percentage candidates enrolled of approached patients)
The proportion of eligible patients who agree to take part in the study.
Measured: 21 months (Recruitment period)
Adherence to intervention - (Percentage candidates who dropout during the intervention period of enrolled candidates)
Proportion of intervention-related dropouts.
Measured: 2 years (Duration of human subjects' involvement)
Adherence to outcome assessment - (Percentage candidates who do not complete outcome assessments of enrolled candidates)
Proportion of patients that complete the assessments at the start and the end of the intervention.
Measured: 2 years (Duration of human subjects' involvement)
Retention - (Percentage candidates who do not complete 6-month follow up of enrolled candidates)
The number of patients who drop out or were 'lost' at the 6-month follow-up.
Measured: 2 years (Duration of human subjects' involvement)
Adverse Events
Rate of adverse and serious adverse events
Measured: 2 years (Duration of human subjects' involvement)
Secondary outcomes (3)
Motor neurological level change (ISNCSCI assessment)
Proportion of patients with Improvement of 2 or more motor zone of partial preservation levels from baseline to 6 months after injury.
Measured: Baseline and 6 months after injury
Incidence of reconnectivity (Proportion: MEP absent, covert to MEP present)
The proportion of re-connectivity will be estimated by treatment group.
Measured: Baseline and 6 months after injury
Change in motor threshold between groups (Difference in %Maximum Stimulator Output to achieve motor threshold)
Change in motor threshold of key muscles will be estimated bilaterally within each group and a comparison of the change between groups.
Measured: Baseline and 6 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start9 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health, University of Mississippi Medical Center, University of Sao Paulo, Massachusetts General Hospital, Weill Medical College of Cornell University, Burke Medical Research Institute
- Responsible party
- Principal investigator, Dylan Edwards, Albert Einstein Healthcare Network
- Investigators
- Dylan J Edwards, PhD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247904
- Sponsor's protocol ID
- iRISID-2023-2494
- Acronym
- NIBS-SCI1
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Upon completion of the study, data will be deidentified and shared within the supplementary material of published scientific papers or per the journal recommendations. We may also share the full range of available individual participant data with the members of the scientific community upon reasonable request and at the discretion of the PI.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Brain Stimulation Therapy in Subacute Human Spinal Cord Injury: A Translational Study
- ClinicalTrials.gov ID
- NCT06247904
- Acronym / sponsor ID
- NIBS-SCI1 / iRISID-2023-2494
- Keywords
- Spinal cord injury, Cervical spinal cord, Transcranial Magnetic Stimulation, Recovery, Motor cortex
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health, University of Mississippi Medical Center, University of Sao Paulo, Massachusetts General Hospital, Weill Medical College of Cornell University, Burke Medical Research Institute
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Feb 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.
No accepted clinical therapies exist for repair of motor pathways following spinal cord injury (SCI) in humans, leaving permanent disability and devastating personal and socioeconomic cost. A robust neural repair strategy has been demonstrated in preclinical studies, that is ready for translation to recovery of hand and arm function in human SCI, comprising daily transcranial magnetic stimulation treatment at the inpatient rehabilitation facility. This study will establish clinical effect size of the intervention, as well as safety and feasibility necessary for a subsequent controlled efficacy trial and inform preclinical studies for dosing optimization.
Detailed description
The objective of this proposal is to begin translating findings from pre-clinical studies to human motor deficits following cervical SCI (cervSCI). This HF-rTMS treatment protocol has not been previously assessed in human SCI and is qualitatively different from rTMS protocols reported to transiently modulate excitability of existing pathways, previously demonstrated in the literature. The protocol involves a daily stimulation of ~10 mins bilateral HF-rTMS for 2 weeks. SCI participants will be studied in a United States inpatient setting for this phase I study.
Given the findings in the pre-clinical model of robust axonal sprouting and functional synapse formation close to the damaged tissue using the above stimulation parameters, the transcranial magnetic stimulation treatment will target the hand-forearm region of the primary motor cortex, bilaterally. The aim is to include the cortical representation of affected muscles adjacent to the neurological level of injury. This zone often contains a mix of clinically and neurophysiologically intact, weakly innervated and denervated corticospinal pathways. Under standard sub-acute rehabilitation care, recovery of up to 1 neurological level of injury (NLI) is often the case, but improvement of 2 or more levels is far less common (<30% of patients). To examine the feasibility and safety of this novel intervention is the principal aim of the study. The associated potential clinical and neurophysiological changes will also be evaluated. These preliminary data will be used to power a subsequent efficacy trial to test the hypothesis that rTMS induced corticospinal augmentation will result in greater than typical extension of the NLI in human SCI, assessed up to the stable recovery phase at 6 months post-injury.
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 |
|---|---|---|
| Active rTMS | Active comparator | Device: Active rTMS10 daily sessions of High-frequency Transcranial Magnetic Stimulation (HF-rTMS) applied bilaterally over the hand primary motor area informed by e-field modelling and targeting will be aided by neuronavigation system for precise targeting during each intervention session. Active group will receive HF-rTMS intensity calculated using electric field modelling to create electric field intensity of approximately motor threshold, using the cool-B65 A/P rTMS coil. |
| Sham rTMS | Sham comparator | Device: sham rTMS10 daily sessions of Sham High-frequency Transcranial Magnetic Stimulation (HF-rTMS) applied bilaterally over the hand primary motor area informed by e-field modelling and targeting will be aided by neuronavigational system for precise targeting during each intervention session Sham group receives no active magnetic stimulation. Cool-B65 A/P rTMS coil will be used to avoid unblinding of administrator and/or study participant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Post traumatic or non-traumatic cervical spinal cord injury (SCI) with residual upper-extremity paralysis
- Time post-injury less than six weeks
- Neurological Level of Injury (NLI) C4-C6
- ASIA Impairment Scale (AIS) A-D
- Sensory and motor zone of partial preservation (ZPP, clinically complete or incomplete)
Key exclusion criteria (9 listed)
- Ventilator dependence;
- Concurrent neurological condition affecting sensory or motor pathways or otherwise limiting ability to participate in the study;
- Evidence of trauma-related brain injury;
- Contraindications for TMS or history of seizure or seizure risk;
- Spinal instability;
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 |
|---|---|---|
| Active rTMSAlso: active repetitive transcranial magnetic stimulationThe stimulation protocol will comprise 15Hz pulse trains, each 50 pulses, repeated 10x, with a 60s inter-train interval. Stimulation intensity will be determined from individual MRI-modeled e-field, to achieve approximately motor threshold in the target area. | Device | Active rTMS |
| sham rTMSAlso: sham repetitive transcranial magnetic stimulationThe stimulation protocol will comprise 15Hz pulse trains, each 50 pulses, repeated 10x, with a 60s inter-train interval. Stimulation intensity will be close to zero (negligible) since sham coil will be used for the intervention | Device | Sham rTMS |
Primary outcome
Eligibility - (Percentage candidates eligible of screened patients)
Time frame: 21 months (Recruitment period)
The proportion of patients who can take part in the study, whether they later agree to or not.
Recruitment - (Percentage candidates enrolled of approached patients)
Time frame: 21 months (Recruitment period)
The proportion of eligible patients who agree to take part in the study.
Adherence to intervention - (Percentage candidates who dropout during the intervention period of enrolled candidates)
Time frame: 2 years (Duration of human subjects' involvement)
Proportion of intervention-related dropouts.
Adherence to outcome assessment - (Percentage candidates who do not complete outcome assessments of enrolled candidates)
Time frame: 2 years (Duration of human subjects' involvement)
Proportion of patients that complete the assessments at the start and the end of the intervention.
Retention - (Percentage candidates who do not complete 6-month follow up of enrolled candidates)
Time frame: 2 years (Duration of human subjects' involvement)
The number of patients who drop out or were 'lost' at the 6-month follow-up.
Adverse Events
Time frame: 2 years (Duration of human subjects' involvement)
Rate of adverse and serious adverse events
3 secondary outcomes
Motor neurological level change (ISNCSCI assessment)
Time frame: Baseline and 6 months after injury
Incidence of reconnectivity (Proportion: MEP absent, covert to MEP present)
Time frame: Baseline and 6 months after injury
Change in motor threshold between groups (Difference in %Maximum Stimulator Output to achieve motor threshold)
Time frame: Baseline and 6 months after injury
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 30 Apr 2025.
- Individual participant dataSharing planned: Yes. Upon completion of the study, data will be deidentified and shared within the supplementary material of published scientific papers or per the journal recommendations. We may also share the full range of available individual participant data with the members of the scientific community upon reasonable request and at the discretion of the PI.
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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.
Dylan J Edwards, PhD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rTMS in people with Traumatic Spinal Cord Injury and Tetraplegia/Tetraparesis, run by Albert Einstein Healthcare Network 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 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 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 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. 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?
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?
Eligibility - (Percentage candidates eligible of screened patients) (time frame: 21 months (Recruitment period)). The study lists 6 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 30 Apr 2025.