Efficacy of rTMS Treatment After Spinal Cord Injury

NCT06464744 | Recruiting DMC

• 1 other identifier: 635283
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

There is accumulating evidence that neuromodulation by repetitive transcranial magnetic stimulation (rTMS) of the motor cortex holds promise as a treatment for rehabilitation of motor function following a spinal cord injury. This study is designed to assess the clinical potential of non-invasive stimulation of the primary motor cortex to improve motor functions.The results will help to evaluate the clinical relevance of motor cortex stimulation for motor functions in patients with spinal cord injury. The outcomes of this study could potentially support the initiation of a larger clinical trial and the development of a new routine treatment.

Conditions

Spinal Cord Injuries; Myelopathy

Keywords

rTMS; rehabilitation; spinal cord injury; motor cortex stimulation

Outcome Measures

Primary Outcomes (6)

• Motor evoked potentials

  Motor evoked potentials will be recorded at the start and the end of each stimulation session.

  From enrollment to the end of follow up at 12 weeks

• Global spasticity

  Spasticity will be evaluated by using the modified Ashworth scale from 0 (no spasticity) to 4 (rigid extremities).

  From enrollment to the end of follow-up at 12 weeks

• Spasticity lower extremities

  The Wartenberg pendulum is an objective test to assess the biomechanical properties of spasticity.The test consists of dropping the leg of a relaxed patient from a horizontal position and measuring oscillatory movements with a goniometer.

  From enrollment to the end of follow-up at 12 weeks

• Nine-Hole Peg Test

  The Nine-Hole Peg Test is used to measure manual dexterity in patients with various neurological diagnoses. It is described in the literature to explore upper extremity function. Patients are asked to take nine pegs (7 mm diameter, 32 mm length) from a container (square box measuring 100 x 100 x 10 mm), one by one, and place them into the holes on the board, as quickly as possible. Scores are based on the time taken to complete the test activity, recorded in seconds.

  From enrollment to the end of follow-up at 12 weeks

• 10-meter walking test

  The 10-meter walk test (10MWT) is used to assess walking capabilities and walking speed in patients with gait impairments. Three trials will be recorded at the patient's fastest walking speed. The three trials are averaged and the gait speeds are documented in meters/second.

  From enrollment to the end of follow-up at 12 weeks

• Lower extremities kinematics

  Movement kinematics will be extracted from recordings with 3D motion capture trackers that will record joint coordinates in time.

  From enrollment to the end of follow-up at 12 weeks

Secondary Outcomes (2)

• Numeric scale rating for pain evaluation

  From enrollment to the end of follow-up at 12 weeks

• European myelopathy score

  From enrollment to the end of follow-up at 12 weeks

Other Outcomes (1)

• Potential adverse effect

  From enrollment to the end of follow-up at 12 weeks

Study Arms (2)

Placebo stimulation

PLACEBO COMPARATOR

Patients will receive stimulation from a placebo coil that only delivers skin tingling but no active brain stimulation.

Procedure: Placebo stimulation using a placebo coil

Active stimulation

ACTIVE COMPARATOR

Patients will receive active brain stimulation from a magnetic figure-of-eight-coil.

Procedure: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

Repetitive transcranial magnetic stimulation (rTMS) PROCEDURE

Intermittent Theta burst stimulation will be delivered on the on the primary motor cortex using a figure-of-eight coil, supported by neuronavigation. The stimulation intensity will be set to 90% of the motor threshold

Active stimulation

Placebo stimulation using a placebo coil PROCEDURE

The placebo coil looks identical to the active coil but it only delivers skin tingling and no active brain stimulation.

Placebo stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years and less than 80 years
• Chronic patients with an incomplete cervical and/or thoracic spinal cord injury (traumatic and non-traumatic) affecting upper and/or lower extremities (i.e., C4-T12 and classified as ASIA C or D) (Figure 138).
• Capable and willing to provide informed consent and able to adhere to the treatment schedule
• Patients who can be followed for the whole duration of the study

You may not qualify if:

• Contraindication to rTMS:
• past severe head trauma
• history of epilepsy or ongoing epilepsy
• active cerebral tumor
• intracranial hypertension
• implanted ferromagnetic devices such as cardiac pacemaker and neurostimulator and cochlear implants
• pregnancy or lactation.
• Any clinically significant or unstable medical or psychiatric disorder
• History of treatment with Deep Brain Stimulation (DBS)
• Subjects protected by law (guardianship or tutelage measure)
• History of substance abuse (alcohol, drugs)
• Pending litigation
• Impossibility to understand the protocol or to fill out the forms
• Chronic use of sedative medication
• Participation in another clinical trial evaluating spinal cord injury

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital - Rikshospitalet

Oslo, 0372, Norway

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Diseases

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Bjørn Atle Bjørnbeth, MD,PhD

  Oslo University Hospital

  STUDY CHAIR

Central Study Contacts

Mark Züchner, MD, PhD

CONTACT

+47 23070000; mark.zuchner@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo motor cortex stimulation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Active motor cortex stimulation

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 18, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)