Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05593237

Transcranial Magnetic Stimulation for Chronic Neuropathic Pain

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

Chronic neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system. It is highly prevalent, debilitating, and challenging to treat. Current available treatments have low efficacy, high side effect burden, and are prone to misuse and dependence. Emerging evidence suggests that the transition from acute to chronic neuropathic pain is associated with reorganization of central brain circuits involved in pain processing. Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative treatment that uses focused magnetic pulses to non-invasively modulate brain activity, a strategy that can potentially circumvent the adverse effects of available treatments for pain. RTMS is FDA-approved for the treatment of major depressive disorder, obsessive-compulsive disorder, and migraine, and has been shown to reduce pain scores when applied to the contralateral motor cortex (M1). However, available studies of rTMS for chronic neuropathic pain typically show variable and often short-lived benefits, and many aspects of optimal treatment remain unknown, including ideal rTMS stimulation parameters, duration of treatment, and relationship to the underlying pain etiology. Here the investigators propose to evaluate the efficacy of high frequency rTMS to M1, the region with most evidence of benefit in chronic neuropathic pain, and to use functional magnetic resonance imaging (fMRI) to identify alternative rTMS targets for participants that do not respond to stimulation at M1. The central aim is to evaluate the pain relieving efficacy of multi-session high-frequency M1 TMS for pain. In secondary exploratory analyses, the investigator propose to investigate patient characteristic that are predictive of responsive to M1 rTMS and identify viable alternative stimulation targets in non-responders to M1 rTMS.

Official title: A Pilot Trial of Longitudinal Repetitive Transcranial Magnetic Stimulation (rTMS) for Chronic Neuropathic Pain

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-04-25

Completion Date

2026-12-30

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Chronic Neuropathic Pain Post-Stroke Pain Trigeminal Neuralgia Nerve Injury Spinal Cord Injuries Pain, Postoperative Complex Regional Pain Syndromes Post-herpetic Neuralgia Nerve Root Avulsion

Interventions

DEVICE

High Frequency rTMS

Stimulation provided at 10 Hz over target brain regions in thirty trains consisting of 10 seconds of stimulation alternating with 50 seconds of rest (3,000 pulses/session)

DEVICE

Low Frequency rTMS

Stimulation provided at 1 Hz over target brain regions in thirty trains consisting of 10 seconds of stimulation alternating with 50 seconds of rest (300 pulses/session)

Inclusion Criteria: * Meets Criteria for Chronic Neuropathic Pain (NP): 1. "Pain caused by a lesion or disease of the somatosensory nervous system 2. Intractable pain longer than 6 months after pain onset 3. Baseline VAS score 30-94-mm 4. Currently prescribed pain medication for NP, history of prior medication trials without adequate pain control, or refused treatments for individual reasons 5. Continuous pain in face and/or extremities * Age 18-80 * Any gender and all ethnoracial categories * Stable on chronic pain medications for 4 weeks prior to the study and agreeable to continue throughout the study. These medications include: Tricyclic antidepressants (e.g., nortriptyline, amitriptyline), SNRIs (e.g., duloxetine, venlafaxine), gabapentinoids (e.g., gabapentin, pregabalin), antiepileptics (e.g., valproic acid, carbamazepine, lamotrigine), and daily anti-inflammatories (e.g., meloxicam), among others (as determined by study physician at the time of screening). Note: Medications that are known to increase cortical excitability (e.g., buproprion, maprotiline, tricyclic antidepressants, classical antipsychotics) or to have an inhibitory effect on brain excitability (e.g., antiepileptics, benzodiazepines, and atypical antipsychotics), or any other medications with relative hazard for use in TMS will be allowed upon review of medications and/or motor threshold determination by TMS specialist. * Participants may continue to take as-needed pain medications and record daily usage throughout the experiment * Capacity to provide informed consent * Ability to tolerate study procedures * Successfully complete the screening forms without contraindications Exclusion Criteria: * Neurologic: Dementia, Severe neurocognitive disorder (MoCA \< 22), Severe aphasia, Seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis), or complete paralysis at target site * Psychiatric: DSM Axis I disorder, Suicidal thoughts, prior psychosurgery, prior ECT * Procedural: prior rTMS within 1 year of consent, enrollment in other clinical trial in the past 6 months * TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics; medications or systemic illness that predispose seizure risk * Participants with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension, cardiac disease) * Females who are pregnant or nursing * Inability to complete the research study

Locations (1)

UCSF Medical Center

San Francisco, California, United States