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

NCT04372134 | Completed

• 1 other identifier: 3
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Spinal Cord Injury

Keywords

r TMS; spinal cord injury; motor recovery,; gait

Outcome Measures

Primary Outcomes (1)

• The lower extremity motor scores of the patients

  The lower extremity motor scores of the patients (degree of muscle strength according to the American Spinal Injury Association (ASIA) Impairment Scale )(The assesment of ASIA scale includes 5 classification as ASIA A, B,C,D,E. ASIA A is the worst score and ASIA E is the best score)

  through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.)

Secondary Outcomes (9)

• the parameters of gait analysis - walking speed

  through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

• the parameters of gait analysis - cadence

  through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

• the parameters of gait analysis - single support time

  through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

• the parameters of gait analysis - double support time

  through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

• the parameters of gait analysis - contralateral foot contact time

  through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)

Study Arms (2)

real rTMS group

ACTIVE COMPARATOR

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

Device: repetitive transcranial magnetic stimulation therapy

sham r TMS

SHAM COMPARATOR

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

Device: repetitive transcranial magnetic stimulation therapy

Interventions

repetitive transcranial magnetic stimulation therapy 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.

Also known as: rehabilitation program

real rTMS group; sham r TMS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• SERDAR KESİKBURUN, MD

  The Scientific and Technological Research Council of Turkey

  STUDY DIRECTOR

• AYÇA URAN ŞAN

  The Scientific and Technological Research Council of Turkey

  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: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: May 1, 2020
• Study Start: October 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share