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COMPLETED

NCT07908420

Accelerated Dual-Protocol rTMS for Refractory Trigeminal Neuralgia

Sponsor: Galileo Medical Center

View on ClinicalTrials.gov

Summary

Brief Summary The goal of this clinical trial is to learn if an accelerated, dual-protocol high-frequency repetitive transcranial magnetic stimulation (rTMS) intervention can treat and achieve long-term pain relief (analgesia) in patients with pharmacologically refractory primary Trigeminal Neuralgia (TN). The main questions it aims to answer are: * Can a combined 10 Hz and 20 Hz rTMS protocol significantly reduce average facial pain intensity (measured via the Visual Analog Scale) at 1 month post-treatment? * Will the induced analgesic effect maintain clinical durability at the 3-month long-term longitudinal checkpoint? * Can this non-invasive treatment significantly down-regulate secondary emotional distress (anxiety and depression) and improve the overall quality of life for chronic pain patients? Participants will: * Undergo a rigorous pre-screening process, including an outpatient clinical examination by an independent neurologist to confirm refractory TN, and a digital EEG to rule out epilepsy or other neurological counter-indications. * Complete an initial baseline assessment using five standardized clinical tests (VAS, BPI, HADS, QoLp, and PGIC) to document pain intensity, symptom distribution, anxiety, depression, and baseline quality of life. * Sign a formal Informed Consent form prior to starting any medical procedures. * Receive non-invasive brain stimulation using the Neurosoft Neuro-MS/D magnetic stimulator, targeted at the primary motor cortex (M1) contralateral (opposite) to the painful facial side. * Complete a 5-day compressed treatment course consisting of 10 total sessions delivered twice daily (a 28-minute 10 Hz protocol followed immediately by a 9-minute 20 Hz protocol per session) with a strict 45-50 minute rest interval between the two daily sessions, totaling 9,000 stimuli per day. * Attend follow-up appointments exactly 1 month and 3 months after completing the treatment course to repeat the same clinical survey battery under identical conditions to track the durability of the therapeutic effect.

Official title: A Prospective, Open-Label Clinical Trial Evaluating the Efficacy, Safety, and Long-Term Durability of an Accelerated, Dual-Protocol High-Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Paradigm Targeting the Contralateral Primary Motor Cortex (M1) for the Induction of Sustained Analgesia in Refractory Trigeminal Neuralgia.

Key Details

Gender

All

Age Range

18 Years - 83 Years

Study Type

OBSERVATIONAL

Enrollment

192

Start Date

2023-03-23

Completion Date

2026-06-26

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Pain Management Psychiatric Comorbidities

Inclusion Criteria: * Confirmed Diagnosis: A verified, unambiguous diagnosis of primary unilateral Trigeminal Neuralgia that meets the strict criteria of the International Classification of Headache Disorders (ICHD-3). * Refractory Status: Documented resistance or severe intolerance to therapeutic doses of first-line medications over a disease duration of at least 12 months. * Baseline Pain Threshold: A mean baseline pain rating of ≥ 3 on the 10-point Visual Analog Scale (VAS) during the 14 days prior to screening. Neurological approval and Safety Screening Clearance. * Medication Stability: Agreement to maintain unchanged dosages of all baseline pharmacological treatments throughout the 5-day active rTMS phase and the entire 3-month follow-up window. * Cognitive Capacity: A Mini-Mental State Examination (MMSE) score of ≥ 24, demonstrating the cognitive ability to understand and complete all psychometric scaling instruments. * Ethical Compliance: The patient must voluntarily provide signed and dated written Informed Consent before the initiation of any protocol-related procedures. Exclusion Criteria: * Neurological and Psychiatric Comorbidities: A personal or direct family history of epilepsy or unprovoked seizures; recent ischemic or hemorrhagic stroke (\< 6 months); severe traumatic brain injury; intracranial tumors or arteriovenous malformations; active severe psychiatric conditions (e.g., schizophrenia, bipolar disorder, or severe major depression with active suicidal ideation). * Ferromagnetic and Electronic Implants: Presence of any metallic hardware or electronic implants within a 30 cm radius of the stimulation coil. This includes cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), deep brain stimulators (DBS), vagus nerve stimulators, cochlear implants, intracranial aneurysm clips, or metallic fragments in the eyes/face. * Prior Destructive Interventions: Microvascular decompression (MVD) or percutaneous destructive rhizotomy performed within the 6 months preceding the trial start. * Atypical Pain Presentations: Diagnosis of atypical facial pain, persistent idiopathic facial pain, post-herpetic neuralgia, or secondary trigeminal neuralgia caused by multiple sclerosis or structural brainstem lesions. * Anatomical Skull Limitations: Significant cranial vault deformities, history of extensive craniotomy, or focal skull bone thinning that would alter the safe distribution of the magnetic fields. * Pregnancy and Nursing: Active pregnancy (verified via a mandatory serum β-hCG test for females of childbearing potential) or active breastfeeding. * General Medical Instability: Severe, unstable cardiac, renal, hepatic, or systemic infectious diseases that compromise patient safety during testing.

Locations (1)

Highly specialized outpatient neurological clinic providing active protocol management using repetitive Transcranial Magnetic Stimulation (rTMS). • Location: Pleven, Bulgaria

Pleven, Pleven, Bulgaria