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Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation Combined With Robotic Rehabilitation on Ambulation in Spinal Cord Injury Patients

G

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Device: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06248476
E2-23-5440

Details and patient eligibility

About

Comparison of different types of transcranial magnetic stimulation techniques which are intermittent theta burst stimulation (iTBS) and high frequency repetitive transcranial magnetic stimulation (rTMS) in patients with spinal cord injury

Full description

iTBS lasts shorter than rTMS so that this technique comfortable than rTMS for both patients and also physicians. Aim of this study is to compare effectiveness of this techniques. If results are same, iTBS can be used instead of rTMS.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Incomplete spinal cord injury (ASIA C and D)
  • 12 months after spinal cord injury
  • At least 10 meters walking independent or with canadian, walker or walking stick
  • Put signature to approved form

Exclusion criteria

  • Epileptic seizure
  • Pacemaker
  • Pregnancy
  • Neurological disease different from spinal cord injury
  • Metalic implant in brain or scalp
  • Brain surgery
  • Orthopedic problem in lower extremity
  • Malignity

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

iTBS + robotic rehabilitation
Active Comparator group
Description:
iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury
Treatment:
Device: Transcranial Magnetic Stimulation
rTMS + robotic rehabilitation
Active Comparator group
Description:
rTMS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury
Treatment:
Device: Transcranial Magnetic Stimulation
sham iTBS + robotic rehabilitation
Sham Comparator group
Description:
Sham iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury
Treatment:
Device: Transcranial Magnetic Stimulation

Trial contacts and locations

1

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Central trial contact

Ayşe Naz Kalem Özgen

Data sourced from clinicaltrials.gov

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