NCT05593237Fut, nem toboroz
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
A Pilot Trial of Longitudinal Repetitive Transcranial Magnetic Stimulation (rTMS) for Chronic Neuropathic Pain
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 14.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 32 (tervezett)
- Első benyújtás
- 2022. okt. 20.
- Kezdés
- 2022. ápr. 25.
- Elsődleges befejezés
- 2026. dec. 30.
- Fő szponzor
- University of California, San Francisco
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT05593237
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 32
- 2022. ápr. 25. és az elsődleges befejezés (2026. dec. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
Más betegség
- 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
- 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)
Egyéb
- Females who are pregnant or nursing
- Inability to complete the research study
Kiket keres a vizsgálat
- Meets Criteria for Chronic Neuropathic Pain (NP):
- "Pain caused by a lesion or disease of the somatosensory nervous system
- Intractable pain longer than 6 months after pain onset
- Baseline VAS score 30-94-mm
- Currently prescribed pain medication for NP, history of prior medication trials without adequate pain control, or refused treatments for individual reasons
- 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
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| UCSF Medical Center Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | San Francisco | Egyesült Államok | Ismeretlen állapot |
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