Spinal Cord InjuryNCT07293780
Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury
A study testing active rTMS of M1 and active rTMS of anterior cingulate cortex in people with Spinal Cord Injury and Neuropathic Pain, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Patients will be randomly assigned to three groups using a randomization scheme: active primary motor cortex (M1) rTMS, active anterior cingulate cortex (ACC) rTMS, or sham M1 rTMS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Neuropathic Pain
- What is being tested?
- active rTMS of M1 and active rTMS of anterior cingulate cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for whom at least 12 months have passed since the date of the spinal cord injury
- Patients who meet the International Spinal Cord Injury Pain (ISCIP) Classification criteria for central neuropathic pain below the level of the lesion and who have had pain for at least 6 months
- Patients aged 18-65
- Pain not attributable to other causes such as rheumatological diseases or diabetes
- Patients with VAS > 4 despite maximum dose of pharmacological agents (anticonvulsants, antidepressants, opioids), exercise and physical therapy agents, taking into account renal function tests and other comorbidities
Who cannot join
- History of epilepsy
- Metallic implant in the scalp
- Cochlear implant
- Spinal cord stimulator
- Pacemaker
- Presence of psychiatric illness
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010
Ayşe Naz Kalem Özgen, +90 0312 797 00 00, kalemnaz@gmail.com
- Recruiting
Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
Ankara, Çankaya, 06800
Hatice Ceylan, Specialist, 0312 2911000, drhaticeceylan@gmail.com
About this study
Official title: The Effect of Transcranial Magnetic Stimulation Applied to the Primary Motor Cortex and Anterior Cingulate Cortex on Refractory Neuropathic Pain in Spinal Cord Injury
Patients will be randomly assigned to three groups using a randomization scheme: active primary motor cortex (M1) rTMS, active anterior cingulate cortex (ACC) rTMS, or sham M1 rTMS. Stimulation will be delivered using a Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, UK) with figure-of-eight active and sham coils or a double-cone coil, depending on the treatment group. All patients will receive 10 sessions of 5 Hz rTMS over two weeks under physician supervision. Stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of stimulation separated by 50-second intervals, delivering a total of 500 pulses. All patients will continue their conventional physical therapy programs throughout the study.
Read the detailed description
This study will be designed as a randomized, double-blind, sham-controlled clinical trial. Eligible patients will be randomly allocated to one of three groups using a computer-generated randomization sequence: active primary motor cortex (M1) repetitive transcranial magnetic stimulation (rTMS), active anterior cingulate cortex (ACC) rTMS, or sham M1 rTMS.
Stimulation will be performed at Etlik City Hospital and Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital using a Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK). Active and sham figure-of-eight coils will be used for M1 stimulation, while a double-cone coil will be used for ACC stimulation.
All participants will undergo 10 rTMS sessions over two consecutive weeks, with five sessions per week, under physician supervision. In the active and sham M1 groups, stimulation will target the lower extremity representation of the primary motor cortex using active or sham stimulation according to group allocation. In the active ACC group, stimulation will target the anterior cingulate cortex. The stimulation frequency will be 5 Hz, and stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous (FDI) muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of 5 Hz stimulation, separated by 50-second inter-train intervals, delivering a total of 500 pulses per session.
The study will employ a double-blind design in which participants and outcome assessors will remain unaware of treatment allocation throughout the study. The physician administering rTMS will be aware of group assignments but will not participate in outcome assessments. All participants will continue their conventional physical therapy programs throughout the intervention period.
This design aims to compare the effects of stimulation targeting different cortical regions on clinical outcomes while minimizing potential bias associated with treatment expectations and outcome assessment.
- Conditions
- Spinal Cord Injury, Neuropathic Pain
- Being tested
- active rTMS of M1, sham TMS, active rTMS of anterior cingulate cortex
- Keywords
- repetitive transcranial magnetic stimulation, anterior cingulate cortex
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMS of M1Device
Patients in the active primary motor cortex rTMS group will receive active rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks with 8 coil. The stimulation frequency will be 5 Hz, and stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous (FDI) muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of 5 Hz stimulation, separated by 50-second inter-train intervals, delivering a total of 500 pulses per session.
sham TMSDevice
Patients in the sham primary motor cortex rTMS group will receive sham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks with sham 8-coil. The stimulation frequency will be 5 Hz, and stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous (FDI) muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of 5 Hz stimulation, separated by 50-second inter-train intervals, delivering a total of 500 pulses per session.
active rTMS of anterior cingulate cortexDevice
Patients in the active anterior cingulate cortex rTMS group will also receive active 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision with double cone coil. The stimulation frequency will be 5 Hz, and stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous (FDI) muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of 5 Hz stimulation, separated by 50-second inter-train intervals, delivering a total of 500 pulses per session.
| Study group | Role | What they receive |
|---|---|---|
| active rTMS primary motor cortex | Active comparator | rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks with 8- coil. Receives: Device: active rTMS of M1 |
| rTMS anterior cingulate gyrus | Experimental | Active 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision with double cone coil. Receives: Device: active rTMS of anterior cingulate cortex |
| sham rTMS primary motor cortex | Sham comparator | sham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks with sham 8 coil. Receives: Device: sham TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale - daytime
The assessment of pain using a 10 cm visual analogue scale (VAS), separately for daytime and night-time. The assessment will be conducted on a scale of "0 = no pain" to "10 = the most severe pain imaginable".
Measured: Baseline, Change from baseline to end of treatment (week 2), Change from baseline to 4 week after end of treatment (week 6), Change from baseline to 12 week after end of treatment (week 14)
visual analog scale - night
The assessment of pain using a 10 cm visual analogue scale (VAS), separately for daytime and night-time. The assessment will be conducted on a scale of "0 = no pain" to "10 = the most severe pain imaginable".
Measured: Baseline, Change from baseline to end of treatment (week 2), Change from baseline to 4 week after end of treatment (week 6), Change from baseline to 12 week after end of treatment (week 14)
Secondary outcomes (3)
neuropathic pain scale
Neuropathic Pain Scale (NPS) will be used to assess the severity and characteristics of neuropathic pain. The scale consists of 10 items evaluating pain intensity, unpleasantness, and specific pain qualities, including sharp, burning, dull, cold, sensitive, and itchy sensations, as well as deep and superficial pain. Each item is scored from 0 to 10, with a total score ranging from 0 to 100. Higher scores indicate greater neuropathic pain severity.
Measured: Baseline, Change from baseline to end of treatment (week 2), Change from baseline to 4 week after end of treatment (week 6), Change from baseline to 12 week after end of treatment (week 14)
Beck Depression Inventory
Beck Depression Inventory (BDI) will be used to assess the severity of depressive symptoms. The inventory consists of 21 self-reported items evaluating cognitive, emotional, and somatic symptoms of depression. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline, Change from baseline to end of treatment (week 2), Change from baseline to 4 week after end of treatment (week 6), Change from baseline to 12 week after end of treatment (week 14)
Patient satisfaction
Patient satisfaction will be assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied), with higher scores indicating greater patient satisfaction.
Measured: End of treatment (week 2), 4 week after end of treatment (week 6), 12 week after end of treatment (week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start15 Dec 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Naz Kalem, Ankara Etlik City Hospital
- Investigators
- Ayşe Naz Kalem, Specialist, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293780
- Sponsor's protocol ID
- AESH-EK-2025-102
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data supporting this study's findings can be obtained from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Magnetic Stimulation Applied to the Primary Motor Cortex and Anterior Cingulate Cortex on Refractory Neuropathic Pain in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07293780
- Acronym / sponsor ID
- AESH-EK-2025-102
- Conditions
- Spinal Cord Injury, Neuropathic Pain
- Keywords
- repetitive transcranial magnetic stimulation, anterior cingulate cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 19 Dec 2025 (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.
Patients will be randomly assigned to three groups using a randomization scheme: active primary motor cortex (M1) rTMS, active anterior cingulate cortex (ACC) rTMS, or sham M1 rTMS. Stimulation will be delivered using a Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, UK) with figure-of-eight active and sham coils or a double-cone coil, depending on the treatment group. All patients will receive 10 sessions of 5 Hz rTMS over two weeks under physician supervision. Stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of stimulation separated by 50-second intervals, delivering a total of 500 pulses. All patients will continue their conventional physical therapy programs throughout the study.
Detailed description
This study will be designed as a randomized, double-blind, sham-controlled clinical trial. Eligible patients will be randomly allocated to one of three groups using a computer-generated randomization sequence: active primary motor cortex (M1) repetitive transcranial magnetic stimulation (rTMS), active anterior cingulate cortex (ACC) rTMS, or sham M1 rTMS.
Stimulation will be performed at Etlik City Hospital and Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital using a Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK). Active and sham figure-of-eight coils will be used for M1 stimulation, while a double-cone coil will be used for ACC stimulation.
All participants will undergo 10 rTMS sessions over two consecutive weeks, with five sessions per week, under physician supervision. In the active and sham M1 groups, stimulation will target the lower extremity representation of the primary motor cortex using active or sham stimulation according to group allocation. In the active ACC group, stimulation will target the anterior cingulate cortex. The stimulation frequency will be 5 Hz, and stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous (FDI) muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of 5 Hz stimulation, separated by 50-second inter-train intervals, delivering a total of 500 pulses per session.
The study will employ a double-blind design in which participants and outcome assessors will remain unaware of treatment allocation throughout the study. The physician administering rTMS will be aware of group assignments but will not participate in outcome assessments. All participants will continue their conventional physical therapy programs throughout the intervention period.
This design aims to compare the effects of stimulation targeting different cortical regions on clinical outcomes while minimizing potential bias associated with treatment expectations and outcome assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| active rTMS primary motor cortex | Active comparator | Device: active rTMS of M1rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks with 8- coil. |
| rTMS anterior cingulate gyrus | Experimental | Device: active rTMS of anterior cingulate cortexActive 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision with double cone coil. |
| sham rTMS primary motor cortex | Sham comparator | Device: sham TMSsham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks with sham 8 coil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients for whom at least 12 months have passed since the date of the spinal cord injury
- Patients who meet the International Spinal Cord Injury Pain (ISCIP) Classification criteria for central neuropathic pain below the level of the lesion and who have had pain for at least 6 months
- Patients aged 18-65
- Pain not attributable to other causes such as rheumatological diseases or diabetes
- Patients with VAS > 4 despite maximum dose of pharmacological agents (anticonvulsants, antidepressants, opioids), exercise and physical therapy agents, taking into account renal function tests and other comorbidities
Key exclusion criteria (7 listed)
- History of epilepsy
- Metallic implant in the scalp
- Cochlear implant
- Spinal cord stimulator
- Pacemaker
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 |
|---|---|---|
| active rTMS of M1Patients in the active primary motor cortex rTMS group will receive active rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks with 8 coil. The stimulation frequency will be 5 Hz, and stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous (FDI) muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of 5 Hz stimulation, separated by 50-second inter-train intervals, delivering a total of 500 pulses per session. | Device | active rTMS primary motor cortex |
| sham TMSPatients in the sham primary motor cortex rTMS group will receive sham rTMS at 5 Hz targeting the M1 area of the lower extremity motor area under medical supervision for a total of 10 sessions over 2 weeks with sham 8-coil. The stimulation frequency will be 5 Hz, and stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous (FDI) muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of 5 Hz stimulation, separated by 50-second inter-train intervals, delivering a total of 500 pulses per session. | Device | sham rTMS primary motor cortex |
| active rTMS of anterior cingulate cortexPatients in the active anterior cingulate cortex rTMS group will also receive active 5 Hz rTMS targeting the anterior cingulate cortex for a total of 10 sessions over 2 weeks under medical supervision with double cone coil. The stimulation frequency will be 5 Hz, and stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous (FDI) muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of 5 Hz stimulation, separated by 50-second inter-train intervals, delivering a total of 500 pulses per session. | Device | rTMS anterior cingulate gyrus |
Primary outcome
visual analog scale - daytime
Time frame: Baseline, Change from baseline to end of treatment (week 2), Change from baseline to 4 week after end of treatment (week 6), Change from baseline to 12 week after end of treatment (week 14)
The assessment of pain using a 10 cm visual analogue scale (VAS), separately for daytime and night-time. The assessment will be conducted on a scale of "0 = no pain" to "10 = the most severe pain imaginable".
visual analog scale - night
Time frame: Baseline, Change from baseline to end of treatment (week 2), Change from baseline to 4 week after end of treatment (week 6), Change from baseline to 12 week after end of treatment (week 14)
The assessment of pain using a 10 cm visual analogue scale (VAS), separately for daytime and night-time. The assessment will be conducted on a scale of "0 = no pain" to "10 = the most severe pain imaginable".
3 secondary outcomes
neuropathic pain scale
Time frame: Baseline, Change from baseline to end of treatment (week 2), Change from baseline to 4 week after end of treatment (week 6), Change from baseline to 12 week after end of treatment (week 14)
Beck Depression Inventory
Time frame: Baseline, Change from baseline to end of treatment (week 2), Change from baseline to 4 week after end of treatment (week 6), Change from baseline to 12 week after end of treatment (week 14)
Patient satisfaction
Time frame: End of treatment (week 2), 4 week after end of treatment (week 6), 12 week after end of treatment (week 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. The data supporting this study's findings can be obtained from the corresponding author upon reasonable request.
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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.
Ayşe Naz Kalem, Specialist principal investigator
Ankara Etlik City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS of M1 and active rTMS of anterior cingulate cortex in people with Spinal Cord Injury and Neuropathic Pain, run by Ankara Etlik City Hospital at 2 sites 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Naz Kalem Özgen, specialist (+90 312 797 00 00, kalemnaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale - daytime (time frame: Baseline, Change from baseline to end of treatment (week 2), Change from baseline to 4 week after end of treatment (week 6), Change from baseline to 12 week after end of treatment (week 14)). The study lists 2 primary outcomes in all. 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 2 Nov 2026.