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

NCT ID: NCT06248476

Last Updated: 2025-03-05

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-12-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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iTBS + robotic rehabilitation

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

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

rTMS + robotic rehabilitation

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

Group Type ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

sham iTBS + robotic rehabilitation

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

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type DEVICE

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

Interventions

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Transcranial Magnetic Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ayse Naz Kalem

Asist. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E2-23-5440

Identifier Type: -

Identifier Source: org_study_id

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