Neuropathic PainNCT05792072
rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
A study testing rTMS in people with Neuropathic Pain and Diabetic Neuropathies, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Diabetic Neuropathies
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2023to 30 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent to participate in this study is obtained
- The subject is an out-patient aged 18 years or above with diabetes mellitus type 1 or 2
- The patient has laboratory-confirmed diabetes
- Patients are diagnosed with peripheral neuropathy based on clinical and electrophysiological findings
- A score of > /= 4 on the the 'Douleur Neuropathique en 4 Questions' (DN4) questionnaire (30), conforming the diagnosis of neuropathic pain.
- The patient has a painful diabetic neuropathy for at least 6 months
- The patient has a Numeric pain rating scale (NPRS) score >/= 4.
- The patient is resistant to standard therapies for neuropathic pain
Who cannot join
- The patient has an implanted cardiac device, such as a pacemaker or a defibrillator
- The patient has an implanted neurostimulator
- The patient has cochlear implants/ear implants, magnetic dental im-plants
- The patient has a drug infusion pump
- The patient has cerebral artery aneurysm clips
- The patient has a history of epilepsy
Show all 10Show fewer
- The patient has a history of migraine or severe headaches
- The patient has significant psychiatric disorders
- For female patients: the subject is pregnant or lactating
- Other formal contra-indication for rTMS or MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Frequency rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients.
This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing, underlying brain metabolism and brain plasticity using rs-fMRI, MRS and Paired-pulse stimulation respectively in those patients.
Read more
Subjects will be randomized into two groups to receive real or sham rTMS protocol. A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects. Sham stimulation will be delivered using a sham coil, providing the same auditory and sensory stimuli.
One daily rTMS session for 5 days of HF-rTMS, will be delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s
- Conditions
- Neuropathic Pain, Diabetic Neuropathies
- Being tested
- rTMS, Sham rTMS
- Medical subject headings
- Neuralgia, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
High-frequency rTMS
Sham rTMSDevice
sham rTMS
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Active comparator | The patient will receive one daily rTMS session for 5 days of HF-rTMS, delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s Receives: Device: rTMS |
| Sham rTMS | Sham comparator | Sham stimulation will be delivered using a sham coil. Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain severity
Neuropathic pain rating scale; Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable
Measured: The NPRS will be controlled at following time points: prior to the initiation of the rTMS protocol, and then weekly until 2 months after the last treatment.
Changes in functional connectivity of the M1 with brain areas involved in pain processing
rs-fMRI will be used
Measured: rs-fMRI will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Changes in brain metabolism
MRS will be used
Measured: MRS will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Changes in brain plasticity
Paired-pulse stimulation will be used
Measured: Paired-pulse stimulation will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Secondary outcomes (3)
Influence on the quality of life
RAND 36-Item Health Survey; It is comprised of 36 items that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. A high score defines a more favorable health state.
Measured: Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
influence on depression
Beck Depression Inventory (BDI-II); total scores ranging from 0 to 63. Higher total scores indicate more severe depressive symptoms
Measured: Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
influence on nerve conduction
Electrodiagnostic testing: This involves nerve conduction studies (NCS) and electromyography (EMG) testing.
During NCS the following measurements will be performed:
- Motor conduction of the peroneal nerve, median motor study
- sensory conduction of the sural nerves, median and ulnar nerve
- Soleus H-reflex
- Sympathic skin respons
EMG study of distal and proximal muscles of at least one upper and lower extremity will be performed.
Measured: this wil be controlled at baseline and 2 months after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start2 May 2023 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
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.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792072
- Sponsor's protocol ID
- TMSDIAB2021
- Status last verified
- Sep 2022
- First submitted
- 7 Dec 2022
- Last updated
- 30 Mar 2023
- 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 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
- ClinicalTrials.gov ID
- NCT05792072
- Acronym / sponsor ID
- TMSDIAB2021
- Conditions
- Neuropathic Pain, Diabetic Neuropathies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 2 May 2023 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 30 Mar 2023 (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.
Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients.
This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing, underlying brain metabolism and brain plasticity using rs-fMRI, MRS and Paired-pulse stimulation respectively in those patients.
Subjects will be randomized into two groups to receive real or sham rTMS protocol. A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects. Sham stimulation will be delivered using a sham coil, providing the same auditory and sensory stimuli.
One daily rTMS session for 5 days of HF-rTMS, will be delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Active comparator | Device: rTMSThe patient will receive one daily rTMS session for 5 days of HF-rTMS, delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s |
| Sham rTMS | Sham comparator | Device: Sham rTMSSham stimulation will be delivered using a sham coil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent to participate in this study is obtained
- The subject is an out-patient aged 18 years or above with diabetes mellitus type 1 or 2
- The patient has laboratory-confirmed diabetes
- Patients are diagnosed with peripheral neuropathy based on clinical and electrophysiological findings
- A score of > /= 4 on the the 'Douleur Neuropathique en 4 Questions' (DN4) questionnaire (30), conforming the diagnosis of neuropathic pain.
Key exclusion criteria (10 listed)
- The patient has an implanted cardiac device, such as a pacemaker or a defibrillator
- The patient has an implanted neurostimulator
- The patient has cochlear implants/ear implants, magnetic dental im-plants
- The patient has a drug infusion pump
- The patient has cerebral artery aneurysm clips
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 |
|---|---|---|
| rTMSHigh-frequency rTMS | Device | active rTMS |
| Sham rTMSsham rTMS | Device | Sham rTMS |
Primary outcome
Changes in pain severity
Time frame: The NPRS will be controlled at following time points: prior to the initiation of the rTMS protocol, and then weekly until 2 months after the last treatment.
Neuropathic pain rating scale; Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable
Changes in functional connectivity of the M1 with brain areas involved in pain processing
Time frame: rs-fMRI will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
rs-fMRI will be used
Changes in brain metabolism
Time frame: MRS will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
MRS will be used
Changes in brain plasticity
Time frame: Paired-pulse stimulation will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Paired-pulse stimulation will be used
3 secondary outcomes
Influence on the quality of life
Time frame: Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
influence on depression
Time frame: Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
influence on nerve conduction
Time frame: this wil be controlled at baseline and 2 months after the last treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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 rTMS in people with Neuropathic Pain and Diabetic Neuropathies, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Mar 2023. 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 Belgium. 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?
Results are not available in the source record.
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?
Changes in pain severity (time frame: The NPRS will be controlled at following time points: prior to the initiation of the rTMS protocol, and then weekly until 2 months after the last treatment.). The study lists 4 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 30 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.