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The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

NCT03690726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-12-29

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury
  • Rehabilitation
  • Transcranial Magnetic Stimulation
  • Neurorehabilitation

Interventions

DEVICE

repetitive transcranial magnetic stimulation

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

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

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Spinal Cord Injury Centre of Western Denmark

    lead OTHER

Principal Investigators

  • Helge Kasch, MD, PhD · Spinal Cord Injury Centre of Western Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2020-08-01
Completion
2020-08-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690726 on ClinicalTrials.gov