NCT06248476

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 27, 2026

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

January 25, 2024

Last Update Submit

February 25, 2026

Conditions

Spinal Cord Injuries

Keywords

Spinal cord injuryrTMSiTBSAmbulationLower extremity motor function

Outcome Measures

Primary Outcomes (1)

  • Lower extremity motor score

    Assesment of lower extremity key motor muscle function according to American Spinal Injury Association

    Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)

Secondary Outcomes (5)

  • Walking index for spinal cord injury II

    Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)

  • Spinal cord injury independence measurement III (SCIM III)

    Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)

  • 10 meter walking test

    Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)

  • Time up and go test

    Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)

  • Motor evoked potential

    Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)

Study Arms (3)

iTBS + robotic rehabilitation

ACTIVE COMPARATOR

iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury

Device: Transcranial Magnetic Stimulation

rTMS + robotic rehabilitation

ACTIVE COMPARATOR

rTMS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury

Device: Transcranial Magnetic Stimulation

sham iTBS + robotic rehabilitation

SHAM COMPARATOR

Sham iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic StimulationDEVICE

Transcranial magnetic stimulation is non-invasive stimulation technique which modifies cortical excitability through forming magnetic field

iTBS + robotic rehabilitationrTMS + robotic rehabilitationsham iTBS + robotic rehabilitation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Dr.

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 8, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

February 27, 2026

Record last verified: 2025-03

Locations

TU(1)