Investigating Modulation of Neuropathic Pain by Transcranial Magnetic Stimulation: a Multimodal Imaging and Electrophysiological Approach

NCT07758348 | Not Yet Recruiting

• 1 other identifier: 202510105DINB
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposed project will combine functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) to identify neurobiological mechanisms underlying how repetitive transcranial magnetic stimulation (rTMS) applied to the primary motor cortex modulates maladaptive neuroplasticity following neuropathic pain.

Conditions

Patients With Neuropathic Pain Due to Peripheral Neuropathy

Keywords

neuropathic pain; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• change in neuropathic pain intensity from the baseline

  measured by visual analog scale (VAS)

  2 weeks after the rTMS interventions

Study Arms (2)

real repetitive TMS experiment

EXPERIMENTAL

Device: repetitive TMS

sham repetitive TMS experiment

SHAM COMPARATOR

Device: sham stimulation

Interventions

repetitive TMS DEVICE

30 trains of TMS pulses delivered at 10 Hz for 10 s (100 pulses/train) with a 20-s intertrain interval, leading to 3000 pulses per session for a total duration of 15 min

real repetitive TMS experiment

sham stimulation DEVICE

the stimulation coil will be tilted 90 degrees away from the scalp. This orientation ensures that the participant experiences the characteristic clicking sound and physical sensation of the TMS machine without the magnetic field reaching the brain.

sham repetitive TMS experiment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18 or older and 90 or younger. 2. Ability to give informed consent. 3. Independent in activity of daily living. 4. Neuropathic pain secondary to peripheral neuropathy (including hereditary neuropathies). The diagnosis of peripheral neuropathy is confirmed by a neurologist, based on clinical symptoms and at least one of the following objective criteria:
• Nerve conduction study: reduced compound muscle action potential (CMAP) or sensory nerve action potential (SNAP) (peroneal nerve: CMAP \< 2 mV, tibial nerve: CMAP \< 6.1 mV, and sural nerve: SNAP \< 5 microV), or prolonged distal motor latencies (\> 5.5 ms), or slowing of motor or sensory nerve conduction velocities (\< 40 m/s), or prolonged minimal F latencies (\> 50 ms) in two or more nerves in the lower limbs.
• Autonomic function test:
• (i) absent sympathetic skin response (SSR); or (ii) reduced R-R interval variability (RRIV) during rest or forced deep breathing, below age-adjusted thresholds (rest/deep breathing: 12%/19% for age 20 \~ 29 years; 6%/9% for age 30 \~ 39 years; 6%/14% for age 40 \~ 49 years; 5%/11% for age 50 \~ 59 years; and 7%/8% for age not less than 60 years).
• Quantitative sensory test: abnormal warm or cold threshold at the foot (warm/cold thresholds: \> 38.6 °C /\< 27.5 °C for age \< 40 years, \> 40.1 °C/\< 26.7 °C for age 40 \~ 59 years, and \> 40.6 °C/\< 27.0 °C for age not less than 60 years).
• Skin biopsy: reduced intraepidermal nerve fiber density at the distal leg (\< 5.88 fibers/mm for age \< 60 years, and \< 2.50 fibers/mm for age not less than 60 years).
• \. Agree not to take caffeine, alcohol, tea and drugs with significant nervous system effects for 48 hours before each study session.

You may not qualify if:

• \. Presence of severe systemic diseases, including severe heart disease, severe lung diseases with dyspnea, severe generalized edema, systemic infection, and uncontrolled migraines due to high intracranial pressure.
• \. Presence of major neurological disorders, including brain tumor, head trauma, and infection or inflammation of the nervous system.
• \. History of epilepsy or family history of seizure disorder. 4. Presence of neurodegenerative disorders involving the brain or spinal cord. 5. Patients suffering from multiple sclerosis. 6. Individuals with large areas of ischemic scarring. 7. Skin damage or lesions on the area of the body to be stimulated (the head). 8. Presence of psychiatric disorders diagnosed by a psychiatrist that may interfere with the subjective assessment of pain, including (i) major depressive disorder with a PHQ-9 score not less than 20 (indicating a severe episode; Kroenke et al. (2001)); (ii) anxiety disorder with a GAD-7 score not less than 15 (at a severe level; Spitzer et al. (2006)), or (iii) post-traumatic stress disorder with a PCL-5 score not less than 32 (exhibiting frequent flashbacks or hyperarousal symptoms; Zuromski et al. (2019)).
• \. Individuals with suicidal ideation within the past year. 10. Presence of implanted medical devices such as a cardiac pacemaker, implantable cardioverter-defibrillator (ICD), cochlear implant, implanted neurostimulator, implanted drug delivery pump, spinal or ventricular drainage device, aneurysm clips, or any metallic foreign object in the body, unless these devices are certified as compatible with MRI or TMS.
• \. Current use of any medication known to lower the seizure threshold. 12. History of sleep disorders during previous TMS sessions. 13. Pregnancy 14. Claustrophobia or any other contraindications to MRI 15. Inability to give informed consent. 16. Drug abuse and alcoholism

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chi-Chao Chao, MD. PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Chao Chao, MD. PhD

CONTACT

+886-2312-3456; b1401019@ms17.hinet.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP