The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)

NCT ID: NCT04372134

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2017-04-01

Brief Summary

It is postulated that high frequency repetitive transcranial magnetic stimulation (rTMS) can decrease the corticospinal inhibition and enhance the motor recovery. This study is aimed to investigate the effect of high frequency rTMS on lower extremity motor recovery and gait parameters in patients with chronic motor incomplete traumatic spinal cord injury (SCI).

Detailed Description

A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance. Lower extremity motor score (LEMS), the temporal-spatial gait parameters measured by 3D gait analysis, Walking Index for SCI-II (WISCI-II) scale and 10 meters walking test were assessed at baseline, 3 weeks (after the treatment sessions) and 5 weeks (follow-up).

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

real rTMS group

motor incomplete traumatic SCI patients receiving real repetitive transcranial magnetic stimulation therapy

Group Type: ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation therapy

Intervention Type: DEVICE

A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (\>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance.

sham r TMS

motor incomplete traumatic SCI patients receiving sham repetitive transcranial magnetic stimulation therapy

Group Type: SHAM_COMPARATOR

repetitive transcranial magnetic stimulation therapy

Intervention Type: DEVICE

A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (\>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance.

Interventions

repetitive transcranial magnetic stimulation therapy

A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (\>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance.

Intervention Type: DEVICE

Other Intervention Names

rehabilitation program

Eligibility Criteria

Inclusion Criteria

• the diagnosis of motor incomplete cervical or thoracic spinal cord injury (ASIA C or D), spinal cord injury due to trauma at least one year previously
• the ability to walk at least 10 meters independently or with assisted devices such as cane / canadian, age (18-45 years). All participants signed the informed consent form.

Exclusion Criteria

• the presence of other musculoskeletal or neurological diseases that may prevent walking, lower motor neuron lesion (cauda equina and conus medullaris)
• family history of epilepsy
• the presence of brain injury
• the presence of cranium defect
• the presence of pacemaker
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasin Demir

Physical Medicine and Rehabilitation Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SERDAR KESİKBURUN, MD

Role: STUDY_DIRECTOR

The Scientific and Technological Research Council of Turkey

AYÇA URAN ŞAN

Role: PRINCIPAL_INVESTIGATOR

The Scientific and Technological Research Council of Turkey

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id