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Completed

NCT Number: NCT03690726

The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

The project will investigate whether repetitive transcranial magnetic stimulation (rTMS) can be used to potentiate/prime spinal cord injured patients' nervous systems for more intense rehabilitation exercise of longer duration - thus leading to greater recovery of motion function. The technique, in which a magnetic coil is positioned above the scalp and forms a magnetic field that activates the desired center of the brain (eg motor cortex), is used in clinical practice for the treatment of a number of disorders. However, although a combination of rTMS and gait training in SCI patients previously has proven beneficial, it is unknown whether additional functional gains can be achieved by combining rTMS and supervised, high-intensity resistance training.

In this project, 30 newly-admitted patients will be recruited and randomized to receive either active rTMS and strength training (n = 15) or sham (imitated) rTMS + strength training, in parallel with standard care. The investigators hypothesize that the active rTMS group will have superior gains in locomotor function and muscle mass, compared to the sham group.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neurorehabilitation Rehabilitation Spinal Cord Diseases Spinal Cord Injuries Transcranial Magnetic Stimulation Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spinal Cord Injury Centre of Western Denmark

Viborg, 8800, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • sub-acute (<6 months) incomplete spinal cord injury
  • admitted at the SCIWDK for primary rehabilitation

Exclusion criteria

  • Medical history of multiple central nervous system lesions,
  • severe structural,
  • inflammatory or degenerative cerebral disorders,
  • epilepsy,
  • other neurological diseases,
  • lower limb peripheral injury,
  • or orthopedic injuries that may limit maximal effort contractions

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training

Sham stimulation

Other

Imitated magnetic stimulation: An active coil will be activated under the subject's head, firing down into the mattress, while an inactive coil will be held over the scalp

Primary outcomes

  1. 6 minutes walking test

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    Test of ambulatory endurance. It measures the maximal distance covered within 6 minutes.

  2. Lower limb maximal muscle strength

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    Measures the maximal voluntary contraction torque of the knee flexors and knee extensors.

  3. Timed up and go test

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    Measures the time (in seconds) it takes a person to get up from an ordinary chair with back and armrest, walk 3 meters, turn back to the chair and sit back.

  4. Rate of force development

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    Measures the explosive muscle force of the knee flexors and knee extensors.

  5. 10 meter walking test

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    Measures the time (in seconds) it takes to cover 10 meters during level-ground walking.

Secondary outcomes

  1. Quantitative Sensory Testing

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    Measures the sensitivity to heat and cold stimuli on the skin.

  2. H-reflex test

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    Measures spasticity from the ratio of the amplitude between the M-wave and H-wave. These are evoked during a short electrical stimulation impulse delivered to the nerves innervating the soleus muscle.

  3. Modified Ashworth Scale

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    A manual test that measures spasticity from 0 to 4, where 0 is no spasticity and 4 is widespread spasticity.

  4. The International Standards for Neurological Classification of Spinal Cord Injury

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    An examination that is used to score the motor and sensory impairment and severity of a spinal cord injury.

  5. Walking Index for Spinal Cord Injury test

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    A test that assesses the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury.

  6. Pressure algometry

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    A test for the pressure sensitivity of the pain nerve fibers in and superficial to the masseter and soleus muscles.

  7. Self-reported pain

    Time frame: Measures the change from baseline and after 8 weeks of intervention

    Examines self-reported pain through a 100mm Visual-Analogue Scale, scored 0-100, where 0 is "no pain" and 100 is "the greatest pain imaginable".

Sponsors and collaborators

Lead sponsor

Spinal Cord Injury Centre of Western Denmark

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

The Effects of Systematic, Repetitive Transcranial Magnetic Stimulation in Rehabilitation After Incomplete Spinal Cord Injury: Neuromuscular Adaptations and Recovery of Lower Limb Muscle Strength

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2018
Registry last updated
Dec 29, 2020

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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