Efficacy of rTMS Treatment After Spinal Cord Injury

NCT ID: NCT06464744

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2029-09-30

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.

Detailed Description

The investigators will recruit 20 patients with low cervical or thoracic ASIA C or D spinal cord injuries based on specific inclusion and exclusion criteria. The patients will be randomized into 2 groups. Each group will receive either the theta burst stimulation or the placebo stimulation. rTMS will be delivered using a figure-of-eight coil positioned on the patient's head, targeting the leg area of the primary motor cortex. After the motor threshold (MT) is determined patients will receive a unilateral 90% subthreshold theta burst stimulation for 3 minutes The protocol includes 15 stimulation sessions over a 3-week period. The 12-week follow up consist of a series of electrophysiological and functional tests to assess upper and lower limb function bilaterally. Secondary outcomes include pain using the NRS scale, and self-reported evaluation of autonomic functions before, during, and after the treatment.

Conditions

Spinal Cord Injuries; Myelopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo stimulation

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

Group Type: PLACEBO_COMPARATOR

Placebo stimulation using a placebo coil

Intervention Type: PROCEDURE

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

Active stimulation

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

Group Type: ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: 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

Interventions

Repetitive transcranial magnetic stimulation (rTMS)

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

Intervention Type: PROCEDURE

Placebo stimulation using a placebo coil

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Other ongoing research protocol or recent past protocol within two months before the inclusion
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mark Züchner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bjørn Atle Bjørnbeth, MD,PhD

Role: STUDY_CHAIR

Oslo University Hospital

Locations

Oslo University Hospital - Rikshospitalet

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Mark Züchner, MD, PhD

Role: CONTACT

mark.zuchner@medisin.uio.no

+47 23070000

Facility Contacts

Mark Züchner, MD, PhD

Role: primary

mark.zuchner@medisin.uio.no

+4723070000

Jean-Luc Boulland, Assoc. Prof.

Role: backup

j.l.boulland@medisin.uio.no

+4722851081

Other Identifiers

635283

Identifier Type: -

Identifier Source: org_study_id