The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

NCT03690726 | Completed DMC

• 1 other identifier: VCR-rTMS
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Rehabilitation; Transcranial Magnetic Stimulation; Neurorehabilitation

Outcome Measures

Primary Outcomes (5)

• 6 minutes walking test

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

  Measures the change from baseline and after 8 weeks of intervention

• Lower limb maximal muscle strength

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

  Measures the change from baseline and after 8 weeks of intervention

• Timed up and go test

  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.

  Measures the change from baseline and after 8 weeks of intervention

• Rate of force development

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

  Measures the change from baseline and after 8 weeks of intervention

• 10 meter walking test

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

  Measures the change from baseline and after 8 weeks of intervention

Secondary Outcomes (7)

• Quantitative Sensory Testing

  Measures the change from baseline and after 8 weeks of intervention

• H-reflex test

  Measures the change from baseline and after 8 weeks of intervention

• Modified Ashworth Scale

  Measures the change from baseline and after 8 weeks of intervention

• The International Standards for Neurological Classification of Spinal Cord Injury

  Measures the change from baseline and after 8 weeks of intervention

• Walking Index for Spinal Cord Injury test

  Measures the change from baseline and after 8 weeks of intervention

Study Arms (2)

Active rTMS

EXPERIMENTAL

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

Sham rTMS

SHAM COMPARATOR

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

Interventions

repetitive transcranial magnetic stimulation DEVICE

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

Active rTMS

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

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spinal Cord Injury Centre of Western Denmark: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Spinal Cord Injury Centre of Western Denmark

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Helge Kasch, MD, PhD

  Spinal Cord Injury Centre of Western Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Research Director, Associate Professor, Clinical Neurology, MD, PhD

Model Details: Randomized Placebo Controlled Clinical Intervention Study

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 1, 2018
• Study Start: January 2, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)