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The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03690726
Recruitment Status : Not yet recruiting
First Posted : October 1, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Helge Kasch, Spinal Cord Injury Centre of Western Denmark

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Rehabilitation Transcranial Magnetic Stimulation Neurorehabilitation Device: repetitive transcranial magnetic stimulation Other: Sham stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Placebo Controlled Clinical Intervention Study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active rTMS
SCI patients fulfilling criteria for participation giving informed written and verbal consent, who are enrolled and randomised to active treatment arm receive consecutive treatment sessions with rTMS directed at cranium and cortex regions as described in protocol.
Device: repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training

Sham Comparator: Sham rTMS
SCI patients fulfilling criteria for participation giving informed written and verbal consent, who are enrolled and randomised to sham/control arm receive consecutive treatment sessions with coil from rTMS that fires at other spot (pillow/mattress) as described in protocol.
Other: Sham stimulation
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 Outcome Measures :
  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 Outcome Measures :
  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".



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sub-acute (<6 months) incomplete,
  • traumatic SCI

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690726


Contacts
Contact: Helge Kasch, MD, PhD 78446177 ext +45 helkas@rm.dk
Contact: Søren K Jensen, MSc 78449854 ext +45 sokrje@rm.dk

Sponsors and Collaborators
Spinal Cord Injury Centre of Western Denmark
University of Southern Denmark
Investigators
Principal Investigator: Helge Kasch, MD, PhD Spinal Cord Injury Centre of Western Denmark

Responsible Party: Helge Kasch, Medical Research Director, Associate Professor, Clinical Neurology, MD, PhD, Spinal Cord Injury Centre of Western Denmark
ClinicalTrials.gov Identifier: NCT03690726     History of Changes
Other Study ID Numbers: VCR-rTMS
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System