The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

Spinal Cord Injury Centre of Western Denmark

Status: Completed

Conditions: Rehabilitation; Transcranial Magnetic Stimulation; Neurorehabilitation; Spinal Cord Injury

Treatments: Device: repetitive transcranial magnetic stimulation; Other: Sham stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03690726

VCR-rTMS

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 2 patient groups

Active rTMS

Experimental group

Description:

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.

Treatment:

Device: repetitive transcranial magnetic stimulation

Sham rTMS

Sham Comparator group

Description:

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.

Treatment:

Other: Sham stimulation