Spinal Cord InjuriesNCT06248476
Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation Combined With Robotic Rehabilitation on Ambulation in Spinal Cord Injury Patients
A study testing Transcranial Magnetic Stimulation in people with Spinal Cord Injuries, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, Çankaya, 06800
About this study
Official title: Effect of Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation Combined With Robotic Rehabilitation on Ambulation and Lower Extremity Motor Function in Chronic Spinal Cord Injury Patients
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
Read the detailed 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Spinal cord injury, rTMS, iTBS, Ambulation, Lower extremity motor function
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Transcranial magnetic stimulation is non-invasive stimulation technique which modifies cortical excitability through forming magnetic field
| Study group | Role | What they receive |
|---|---|---|
| iTBS + robotic rehabilitation | Active comparator | iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury Receives: 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 Receives: 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 Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity motor score
Assesment of lower extremity key motor muscle function according to American Spinal Injury Association
Measured: 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
Assesment of ambulation ability after spinal cord injury
Measured: 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)
Assesment of independence of daily living activities in patients with spinal cord injury
Measured: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
10 meter walking test
Patients with spinal cord injury walk between two markers, that distance is 10 meters
Measured: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
Time up and go test
Patients sit chair, then walk 3 meter, return and sit again
Measured: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
Motor evoked potential
For assesment of cortical excitability
Measured: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Naz Kalem, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248476
- Sponsor's protocol ID
- E2-23-5440
- Status last verified
- Mar 2025
- First submitted
- 25 Jan 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Theta Burst Stimulation and Repetitive Transcranial Magnetic Stimulation Combined With Robotic Rehabilitation on Ambulation and Lower Extremity Motor Function in Chronic Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT06248476
- Acronym / sponsor ID
- E2-23-5440
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injury, rTMS, iTBS, Ambulation, Lower extremity motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iTBS + robotic rehabilitation | Active comparator | Device: Transcranial Magnetic StimulationiTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury |
| rTMS + robotic rehabilitation | Active comparator | Device: Transcranial Magnetic StimulationrTMS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury |
| sham iTBS + robotic rehabilitation | Sham comparator | Device: Transcranial Magnetic StimulationSham iTBS combined with robotic rehabilitation and conservative treatment applied to patients with chronic incomplete spinal cord injury |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Epileptic seizure
- Pacemaker
- Pregnancy
- Neurological disease different from spinal cord injury
- Metalic implant in brain or scalp
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationTranscranial magnetic stimulation is non-invasive stimulation technique which modifies cortical excitability through forming magnetic field | Device | iTBS + robotic rehabilitation, rTMS + robotic rehabilitation, sham iTBS + robotic rehabilitation |
Primary outcome
Lower extremity motor score
Time frame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
Assesment of lower extremity key motor muscle function according to American Spinal Injury Association
5 secondary outcomes
Walking index for spinal cord injury II
Time frame: 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)
Time frame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
10 meter walking test
Time frame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
Time up and go test
Time frame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
Motor evoked potential
Time frame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Spinal Cord Injuries, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity motor score (time frame: Before treatment (0. week), finishing time of treatment (2.week), 4 weeks after finishing time of treatment (6.week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.