Neuropathic PainRTMS-CLBPNCT07468799
High-Frequency rTMS Over the DLPFC for Chronic Low Back Pain
A study testing Repetitive Transcranial Magnetic Stimulation in people with Neuropathic Pain and Chronic Neuropathic Pain, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
Neuropathic pain is a chronic condition that significantly affects quality of life and often responds poorly to conventional pharmacological treatments. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a non-invasive neuromodulation technique with potential analgesic effects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathic Pain, Chronic Neuropathic Pain
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 1 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Diagnosed with schizophrenia according to DSM-5 criteria
- Experiencing neuropathic pain or chronic pain symptoms
- Stable psychiatric medication for at least 4 weeks prior to enrollment
- Able to provide written informed consent
Who cannot join
- History of epilepsy or seizure disorders
- Presence of metallic implants in the head
- Severe neurological disorders
- Substance abuse within the past 6 months
- Pregnancy or breastfeeding
- Contraindications to rTMS therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Frequency Repetitive Transcranial Magnetic Stimulation Over the Dorsolateral Prefrontal Cortex Enhances IL-10 and Reduces Pain in Chronic Low Back Pain: A Randomized Controlled Trial
Neuropathic pain is a chronic condition that significantly affects quality of life and often responds poorly to conventional pharmacological treatments. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a non-invasive neuromodulation technique with potential analgesic effects.
This study aimed to evaluate the effectiveness of rTMS in reducing neuropathic pain intensity among patients with confirmed neuropathic pain. A clinical study was conducted involving adult patients who met diagnostic criteria for neuropathic pain. Participants received rTMS sessions targeting the motor cortex over a defined treatment period.
Read more
Pain intensity was assessed using standardized pain scales before and after treatment. The study examined changes in pain scores following rTMS therapy and evaluated its potential as an adjunctive treatment for neuropathic pain.
The findings of this study may contribute to understanding the therapeutic role of rTMS in the management of neuropathic pain and support its use as a non-invasive treatment option.
Read the detailed description
Neuropathic pain is caused by lesions or diseases affecting the somatosensory nervous system and is often difficult to manage with conventional pharmacological treatments. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that modulates cortical excitability and has been investigated as a potential treatment for neuropathic pain.
This study was conducted to evaluate the effectiveness of rTMS therapy in patients diagnosed with neuropathic pain. Eligible patients who met the diagnostic criteria for neuropathic pain were enrolled and received rTMS stimulation targeting the primary motor cortex (M1). The stimulation protocol followed standard clinical parameters used for pain modulation.
Participants underwent multiple rTMS sessions during the treatment period. Pain intensity was evaluated using validated pain assessment scales before treatment and after completion of the rTMS sessions. The primary objective was to determine whether rTMS therapy could significantly reduce pain intensity in patients with neuropathic pain.
Secondary observations included the tolerability of the intervention and clinical responses among participants following the stimulation protocol. Data were analyzed to compare pain scores before and after treatment.
The study was conducted in accordance with ethical standards and approved by the institutional ethics committee. The results aim to provide evidence regarding the role of rTMS as a therapeutic option for neuropathic pain management.
- Conditions
- Neuropathic Pain, Chronic Neuropathic Pain
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, rTMS, Neuromodulation, Chronic Pain, Motor Cortex Stimulation
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called rTMS
Repetitive transcranial magnetic stimulation (rTMS) delivered over the primary motor cortex using a magnetic coil to generate repeated magnetic pulses. The stimulation sessions are administered to modulate cortical excitability and reduce neuropathic pain symptoms. Participants receive multiple treatment sessions according to the study protocol, and clinical outcomes are evaluated before and after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| rTMS Treatment | Experimental | Participants receive repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex as a therapeutic intervention for neuropathic pain. Clinical outcomes including pain severity and inflammatory biomarkers are assessed before and after the intervention. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity score
Change in neuropathic pain intensity measured using the Visual Analog Scale (VAS). Pain scores are assessed before the rTMS intervention and after completion of the treatment sessions.
Measured: Baseline and immediately after completion of the rTMS treatment sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm interventional study evaluating the effect of repetitive transcranial magnetic stimulation (rTMS) on neuropathic pain. Participants receive rTMS sessions targeting the primary motor cortex, and clinical outcomes including pain severity and inflammatory biomarkers are assessed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jumraini Tammasse, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468799
- Sponsor's protocol ID
- UNHAS-RTMS-CLBP-2024
- Other IDs
- 012/UNHAS/LPPM/2025
- Acronym
- RTMS-CLBP
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Frequency Repetitive Transcranial Magnetic Stimulation Over the Dorsolateral Prefrontal Cortex Enhances IL-10 and Reduces Pain in Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07468799
- Acronym / sponsor ID
- RTMS-CLBP / UNHAS-RTMS-CLBP-2024
- Conditions
- Neuropathic Pain, Chronic Neuropathic Pain
- Keywords
- Repetitive Transcranial Magnetic Stimulation, rTMS, Neuromodulation, Chronic Pain, Motor Cortex Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Mar 2026 (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.
Neuropathic pain is a chronic condition that significantly affects quality of life and often responds poorly to conventional pharmacological treatments. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a non-invasive neuromodulation technique with potential analgesic effects.
This study aimed to evaluate the effectiveness of rTMS in reducing neuropathic pain intensity among patients with confirmed neuropathic pain. A clinical study was conducted involving adult patients who met diagnostic criteria for neuropathic pain. Participants received rTMS sessions targeting the motor cortex over a defined treatment period.
Pain intensity was assessed using standardized pain scales before and after treatment. The study examined changes in pain scores following rTMS therapy and evaluated its potential as an adjunctive treatment for neuropathic pain.
The findings of this study may contribute to understanding the therapeutic role of rTMS in the management of neuropathic pain and support its use as a non-invasive treatment option.
Detailed description
Neuropathic pain is caused by lesions or diseases affecting the somatosensory nervous system and is often difficult to manage with conventional pharmacological treatments. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that modulates cortical excitability and has been investigated as a potential treatment for neuropathic pain.
This study was conducted to evaluate the effectiveness of rTMS therapy in patients diagnosed with neuropathic pain. Eligible patients who met the diagnostic criteria for neuropathic pain were enrolled and received rTMS stimulation targeting the primary motor cortex (M1). The stimulation protocol followed standard clinical parameters used for pain modulation.
Participants underwent multiple rTMS sessions during the treatment period. Pain intensity was evaluated using validated pain assessment scales before treatment and after completion of the rTMS sessions. The primary objective was to determine whether rTMS therapy could significantly reduce pain intensity in patients with neuropathic pain.
Secondary observations included the tolerability of the intervention and clinical responses among participants following the stimulation protocol. Data were analyzed to compare pain scores before and after treatment.
The study was conducted in accordance with ethical standards and approved by the institutional ethics committee. The results aim to provide evidence regarding the role of rTMS as a therapeutic option for neuropathic pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm interventional study evaluating the effect of repetitive transcranial magnetic stimulation (rTMS) on neuropathic pain. Participants receive rTMS sessions targeting the primary motor cortex, and clinical outcomes including pain severity and inflammatory biomarkers are assessed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| rTMS Treatment | Experimental | Device: Repetitive Transcranial Magnetic StimulationParticipants receive repetitive transcranial magnetic stimulation (rTMS) applied over the primary motor cortex as a therapeutic intervention for neuropathic pain. Clinical outcomes including pain severity and inflammatory biomarkers are assessed before and after the intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years
- Diagnosed with schizophrenia according to DSM-5 criteria
- Experiencing neuropathic pain or chronic pain symptoms
- Stable psychiatric medication for at least 4 weeks prior to enrollment
- Able to provide written informed consent
Key exclusion criteria (6 listed)
- History of epilepsy or seizure disorders
- Presence of metallic implants in the head
- Severe neurological disorders
- Substance abuse within the past 6 months
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: rTMSRepetitive transcranial magnetic stimulation (rTMS) delivered over the primary motor cortex using a magnetic coil to generate repeated magnetic pulses. The stimulation sessions are administered to modulate cortical excitability and reduce neuropathic pain symptoms. Participants receive multiple treatment sessions according to the study protocol, and clinical outcomes are evaluated before and after the intervention. | Device | rTMS Treatment |
Primary outcome
Pain intensity score
Time frame: Baseline and immediately after completion of the rTMS treatment sessions
Change in neuropathic pain intensity measured using the Visual Analog Scale (VAS). Pain scores are assessed before the rTMS intervention and after completion of the treatment sessions.
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 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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 Repetitive Transcranial Magnetic Stimulation in people with Neuropathic Pain and Chronic Neuropathic Pain, run by Hasanuddin University at 1 site in Indonesia.
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 6 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 13 Mar 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 Indonesia. 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. 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?
Pain intensity score (time frame: Baseline and immediately after completion of the rTMS treatment sessions). 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 13 Mar 2026.