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The Effects of rTMS in Rehabilitation Following Spinal Cord Injury

NCT ID: NCT03690726

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2020-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury Rehabilitation Transcranial Magnetic Stimulation Neurorehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Placebo Controlled Clinical Intervention Study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type 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

Interventions

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repetitive transcranial magnetic stimulation

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

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Spinal Cord Injury Centre of Western Denmark

OTHER

Sponsor Role lead

Responsible Party

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Helge Kasch

Medical Research Director, Associate Professor, Clinical Neurology, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helge Kasch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Spinal Cord Injury Centre of Western Denmark

Locations

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Spinal Cord Injury Centre of Western Denmark

Viborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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VCR-rTMS

Identifier Type: -

Identifier Source: org_study_id