An interventional study of Active rTMS and sham rTMS in Traumatic Spinal Cord Injury and Tetraplegia/Tetraparesis, sponsored by Albert Einstein Healthcare Network. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Albert Einstein Healthcare Network · Not applicable, Interventional, and Treatment
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.
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.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
This study's planned enrollment of 20 is above the median of 15 across 193 interventional studies indexed under Quadriplegia.
Browse Quadriplegia studies →Albert Einstein Healthcare Network is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Active rTMS
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.
Device: sham rTMS
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.
Also known as: 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 close to zero (negligible) since sham coil will be used for the intervention
Also known as: sham repetitive transcranial magnetic stimulation
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.
Time frame: 21 months (Recruitment period)
Recruitment - (Percentage candidates enrolled of approached patients)
The proportion of eligible patients who agree to take part in the study.
Time frame: 21 months (Recruitment period)
Adherence to intervention - (Percentage candidates who dropout during the intervention period of enrolled candidates)
Proportion of intervention-related dropouts.
Time frame: 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.
Time frame: 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.
Time frame: 2 years (Duration of human subjects' involvement)
Adverse Events
Rate of adverse and serious adverse events
Time frame: 2 years (Duration of human subjects' involvement)
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 months after injury
Plan to share: 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.
Supporting information: Statistical analysis plan, Analytic code
Time frame: Data will become available upon publication of results and may be shared indefinitely.
Access criteria: IPD and any additional supporting information will be shared with members of the scientific and medical communities for analyses related to the use of rTMS to improve upper extremity motor function following neurological insult. The mechanism for data sharing will be decided on a case by case basis; the study PI will review all data sharing request.
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2025, 8 months after the start.
Of 77 non-industry interventional studies with no phase under Quadriplegia, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 309. This study's planned 8 months is below that.
Counting every sponsor, half of 97 studies reached it within 41 months; a quarter within 15 and three quarters within 309.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Albert Einstein Healthcare Network