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NCT Number: NCT06464744

Efficacy of rTMS Treatment After Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Myelopathy Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital - Rikshospitalet

Oslo, 0372, Norway

Location status: Recruiting

Location contact

Akif Yucesoy, MD cand.

SUB_INVESTIGATOR

Ana Isabel Reinartz Groba, MSc

SUB_INVESTIGATOR

Bjørn-Erik Juel, MSc, PhD

SUB_INVESTIGATOR

Eis Annavini, MSc, PhD

SUB_INVESTIGATOR

Jean-Luc Boulland, Assoc. Prof.

CONTACT

[email protected]

+4722851081

Jean-Luc Boulland, Assoc.Prof.

SUB_INVESTIGATOR

Lars Etholm, MD, PhD

SUB_INVESTIGATOR

Mark Züchner, MD, PhD

CONTACT

[email protected]

+4723070000

Mark Züchner, MD, PhD

PRINCIPAL_INVESTIGATOR

Rozan Albanna, MD

SUB_INVESTIGATOR

Sara Maria Allen, MCs

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

6.3 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

Treatment and study plan

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

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.

Primary outcomes

  1. Motor evoked potentials

    Time frame: From enrollment to the end of follow up at 12 weeks

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

  2. Global spasticity

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

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

  3. Spasticity lower extremities

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

    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.

  4. Nine-Hole Peg Test

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

    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.

  5. 10-meter walking test

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

    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.

  6. Lower extremities kinematics

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

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

Secondary outcomes

  1. Numeric scale rating for pain evaluation

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

    The analgesic efficacy of the stimulation protocol will be measured by the numeric scale rating (NRS), a self-reported measure in which patients rate their pain on a scale from 0 (no pain) to 10 (worst pain).

  2. European myelopathy score

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

    The European myelopathy score is a reliable tool to assess functional recovery. The score ranges from 5 to 18. Higher values indicate better neurological function (outcome).

Other outcomes

  1. Potential adverse effect

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

    In general, rTMS is a safe method. The use of exclusion criteria and ear plugs during stimulation will reduce side effects. Potential risks or side effects of rTMS include:

    • Displacement of ferromagnetic device
    • Headache (3% in conventional rTMS studies) because of the noise generated by the stimulation
    • Seizures (0,16% in conventional rTMS studies) particularly in those with past epilepsy or brain surgery
    • Application site pain or discomfort and jaw pain

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Züchner, MD, PhD

CONTACT

[email protected]

+47 23070000

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Investigating the Efficacy of rTMS Treatment in Improving Motor Function After Spinal Cord Injury: A Placebo-controlled Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jun 18, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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