NIBS Therapy in Subacute Spinal Cord Injury

NCT06247904 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: iRISID-2023-2494
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Traumatic Spinal Cord Injury; Tetraplegia/Tetraparesis

Keywords

Spinal cord injury; Cervical spinal cord; Transcranial Magnetic Stimulation; Recovery; Motor cortex

Outcome Measures

Primary Outcomes (6)

• 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.

  21 months (Recruitment period)

• Recruitment - (Percentage candidates enrolled of approached patients)

  The proportion of eligible patients who agree to take part in the study.

  21 months (Recruitment period)

• Adherence to intervention - (Percentage candidates who dropout during the intervention period of enrolled candidates)

  Proportion of intervention-related dropouts.

  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.

  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.

  2 years (Duration of human subjects' involvement)

• Adverse Events

  Rate of adverse and serious adverse events

  2 years (Duration of human subjects' involvement)

Secondary Outcomes (3)

• Motor neurological level change (ISNCSCI assessment)

  Baseline and 6 months after injury

• Incidence of reconnectivity (Proportion: MEP absent, covert to MEP present)

  Baseline and 6 months after injury

• Change in motor threshold between groups (Difference in %Maximum Stimulator Output to achieve motor threshold)

  Baseline and 6 months after injury

Study Arms (2)

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.

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.

Device: sham rTMS

Interventions

Active rTMS DEVICE

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

Active rTMS

sham rTMS DEVICE

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

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• Pennsylvania Department of Health: collaborator
• University of Mississippi Medical Center: collaborator
• University of Sao Paulo: collaborator
• Massachusetts General Hospital: collaborator
• Weill Medical College of Cornell University: collaborator
• Burke Medical Research Institute: collaborator

Study Sites (1)

Jefferson Moss-Magee Rehabilitation - Elkins Park

Elkins Park, Pennsylvania, 19027, United States

Location

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Dylan J Edwards, PhD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients will be equally randomized to either the Active rTMS or Sham rTMS group following the Baseline Assessment. Device will be set up to active/sham mode prior to intervention using a unique patient and intervention code by an unblinded study team member. Subjects, outcome assessors and staff administering rTMS intervention (care provider) will be blinded to the device setting (Active/Sham).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Jefferson Moss Rehabilitation Research Institute

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: April 9, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, 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.

Locations

US (1)