AzTrials
AzTrials

Pain ManagementrTMS-TN-M1NCT07908420

Accelerated Dual-Protocol rTMS for Refractory Trigeminal Neuralgia

An observational study of Pain Management and Psychiatric Comorbidities, run by Galileo Medical Center at 1 site in Bulgaria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 83 years
Conditions the study is for
Pain Management, Psychiatric Comorbidities
How many people
192 participants
Where
1 siteBulgaria
Study dates
23 Mar 2023to 26 Jun 2026
Phase
Observational
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 to 83 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Study Population Description The study population consists of adult outpatients aged 18 to 85 years diagnosed with severe, pharmacologically refractory primary unilateral Trigeminal Neuralgia (TN). Participants are recruited from specialized neurology clinics, tertiary headache centers, and neurosurgical referral channels. This cohort represents individuals experiencing chronic, severe neuropathic facial pain that has failed to respond to standard guideline-based medical therapies (such as carbamazepine, oxcarbazepine, and secondary add-on agents) or who suffer from treatment-limiting side effects from these medications. The population reflects a real-world clinical sample of drug-resistant cranial neuropathy patients who have preserved cognitive capacity (MMSE ≥ 24) and have been cleared of any latent epileptic or structural brain risks via mandatory independent neurological and digital EEG screening. Non-Probability Sample Consecutive Sampling

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Bulgaria1 site

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

    Pleven, Pleven, 5800

Other trials in Bulgaria

About this study

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.

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:

Read more
  • 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.
Read the detailed description

Project Summary: Repetitive Transcranial Magnetic Stimulation (rTMS) for Refractory Trigeminal Neuralgia

  1. Abstract / Executive Summary This project evaluates the therapeutic efficacy and long-term analgesic effects of an innovative, high-intensity repetitive Transcranial Magnetic Stimulation (rTMS) protocol for patients with refractory Trigeminal Neuralgia (TN). Using the high-performance Neuro-MS/D magnetic stimulator (Neurosoft), the study implements a dual-protocol, accelerated schedule delivered twice daily over 5 business days. Patients undergo a rigorous, multi-stage screening process (including independent neurological exams and EEG) to ensure safety and confirm diagnosis. Therapeutic outcomes, including pain intensity, spatial distribution, anxiety, depression, and overall quality of life, are systematically tracked at baseline, 1 month, and 3 months post-treatment using standardized clinical scales (VAS, BPI, HADS, QoLp, and PGIC). The ultimate goal is to establish a noninvasive neuromodulatory framework capable of inducing sustained, long-term analgesia for drug-resistant facial pain.
  2. Background and Clinical Justification Trigeminal Neuralgia (TN) is marked by excruciating, electric-shock-like paroxysmal pain confined to the distribution of one or more branches of the trigeminal nerve. When conventional pharmacological treatments (such as carbamazepine or oxcarbazepine) fail because of lack of efficacy or intolerable systemic side effects, the condition is classified as refractory TN. Neurostimulation with rTMS offers a safe, noninvasive alternative. High-frequency rTMS applied over the primary motor cortex (M1) contralateral to the painful facial side has been shown to modulate the central pain matrix. It triggers long-term potentiation (LTP)-like plasticity, alters thalamocortical pathways, and activates descending inhibitory pain control systems. This project seeks to optimize these mechanisms by using a novel dual-frequency accelerated paradigm to maximize cumulative neuroplastic changes and prolong pain relief.
  3. Study Design and Patient Workflow The study uses a longitudinal, prospective design organized into four distinct phases over a 3-month observation window per participant: [Phase 1: Pre-Screening] ➔ Independent Neurological Exam \& EEG Diagnostics ▼ [Phase 2: Baseline Assessment] ➔ Informed Consent \& Pre-treatment Psychometric Scales ▼ [Phase 3: Therapeutic Intervention] ➔ 10 rTMS Sessions (Twice daily for 5 consecutive days) ▼ [Phase 4: Follow-Up Monitoring] ➔ Re-evaluation at Month 1 and Month 3 Post-Intervention
  4. Selection Criteria and Patient Screening To ensure high internal validity and absolute patient safety, candidate selection is subject to strict eligibility criteria:
  • Neurological Confirmation: Every patient must be evaluated by an independent neurologist to confirm a primary diagnosis of Trigeminal Neuralgia and to document clear resistance to standard medical therapies.
  • Safety Screening (EEG): A routine Electroencephalography (EEG) is performed to rule out subclinical epilepsy, epileptiform activity, or structural brain abnormalities that could lower the seizure threshold during high-frequency magnetic stimulation.
  • Ethical Compliance: Prior to enrollment, patients are fully counseled on the procedure, potential minor risks (e.g., transient headache), and study details, culminating in the signing of an Informed Consent Form.
  1. Technical Specifications \& Interventional rTMS Protocol Brain stimulation is delivered using the Neuro-MS/D system manufactured by Neurosoft. The focal point of stimulation is the primary motor cortex (M1) on the side of the brain opposite the patient's affected facial side. The treatment regimen consists of 10 sessions delivered over 5 consecutive working days. Each day, patients receive two distinct therapeutic blocks configured as follows: Parameter Specification Protocol Layer 1 Protocol Layer 2 Stimulation Frequency 10 Hz (High-Frequency) 20 Hz (High-Frequency) Duration per Session 28 Minutes 9 Minutes Total Session Runtime 37 Minutes Anatomical Target Contralateral M1 Contralateral M1
  • Daily Schedule \& Inter-Session Interval: Sessions are administered twice daily. To prevent cortical over-excitation while optimizing cumulative synaptic plasticity, a strict 45- to 50-minute rest interval is maintained between the two daily sessions.
  • Total Volume of Stimulation: The accelerated protocol delivers exactly 9,000 stimuli per treatment day, ensuring a dense neuromodulation dose.
  1. Psychometric Evaluation \& Outcome Measures Given the profound toll that chronic pain takes on a patient's mental health and social functioning, a multidimensional testing framework is applied. Given the profound toll chronic pain takes on a patient's mental health and social functioning, a multidimensional testing framework is used. Measurements are collected at three key intervals: Baseline (pre-treatment), Month 1, and Month 3.
  • Visual Analog Scale (VAS): Quantifies immediate, subjective pain intensity using a validated 0-10 scale.
  • Brief Pain Inventory (BPI): Assesses pain topography, daily fluctuations, and the specific interference of pain with daily activities.
  • Hospital Anxiety and Depression Scale (HADS): Measures emotional distress and isolates levels of anxiety and depressive symptomatology triggered by long-term pain exposure.
  • Quality of Life Pain Scale (QoLp): Evaluates the broader socioeconomic and functional impact of chronic facial pain on the patient's overall well-being.
  • Patient Global Impression of Change (PGIC): Reflects the patient's holistic evaluation of clinical improvement or stabilization post-therapy. Measurements are collected at three key intervals: Baseline (pre-treatment), Month 1, and Month 3.
  • Visual Analog Scale (VAS): Quantifies immediate, subjective pain intensity on a validated 0-10 metric.
  • Brief Pain Inventory (BPI): Assesses pain topography, daily fluctuations, and the specific interference of pain with daily life activities.
  • Hospital Anxiety and Depression Scale (HADS): Measures emotional distress, isolating levels of anxiety and depressive symptomatology triggered by long-term pain exposure.
  • Quality of Life Pain Scale (QoLp): Evaluates the broader socio-economic and functional impact of chronic facial pain on the patient's overall well-being.
  • Patient Global Impression of Change (PGIC): Reflects the patient's personal, holistic evaluation of clinical improvement or stabilization post-therapy.
  1. Expected Clinical Outcomes and Scientific Impact

The primary objective of this clinical trial is to achieve a statistically significant and sustained reduction in pain scores (measured by VAS and BPI) at short-term (1 month) and mid-term (3 months) checkpoints. By delivering combined 10 Hz and 20 Hz sequences via the Neurosoft Neuro-MS/D platform, this research aims to demonstrate that accelerated, dual-protocol stimulation yields superior analgesic durability compared with standard single-session regimens. Ultimately, the data generated will contribute to the standardization of non-invasive, non-pharmacological neuromodulation protocols within international clinical guidelines for refractory cranial neuropathies.

Keywords
rTMS, Trigeminal neuralgia, Neuropathic pain
Medical subject headings
Agnosia, Trigeminal Neuralgia, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07908420
Study groupRoleWhat they receive
Active rTMS group n=108•All enrolled participants are assigned to this single active treatment group. Patients receive a high-density, accelerated course of non-invasive brain stimulation consisting of 10 therapeutic sessions delivered twice daily over 5 consecutive working days. Stimulation is targeted at the primary motor cortex (M1) contralateral (opposite) to the clinically reported facial pain using the Neurosoft Neuro-MS/D magnetic stimulator. Each treatment day delivers a total volume of 9,000 stimuli, split across two sessions separated by a strict 45-50 minute rest interval. * Intervention Type: Device (Repetitive Transcranial Magnetic Stimulation) * Intervention Name: Neurosoft Neuro-MS/D Dual-Frequency Paradigm * Intervention Details: Brain stimulation is delivered via a Neurosoft liquid-cooled figure-of-eight coil calibrated at 80% to 90% of the patient's individual resting motor threshold (rMT).
Optimized pharmacological care control cohort n=84• Arm Description: Participants assigned to this group do not receive rTMS neuromodulation. Instead, they continue with optimized standard pharmacological treatment for primary Trigeminal Neuralgia as managed by their primary neurologist. This includes maintaining optimized, stable baseline dosages of standard first-line membrane-stabilizing anticonvulsant agents (such as carbamazepine or oxcarbazepine) and/or secondary adjunctive therapies (such as gabapentin, pregabalin, baclofen, or lamotrigine). This group serves as the clinical baseline comparator to isolate the therapeutic effect size, onset speed, and long-term durability of the accelerated rTMS intervention versus conventional pharmacological management over the 3-month tracking timeline. * Intervention Type: Drug (Standard Pharmacotherapy) * Intervention Name: Guideline-Based Medical Management * Intervention Details: Patients undergo regular clinical check-ups and medical management according to national guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Patient-Reported Facial Pain Intensity via the Visual Analog Scale (VAS)

    The primary efficacy endpoint is the sub-acute reduction of self-reported facial pain intensity. Pain is measured using a standardized 100 mm Visual Analog Scale (VAS), where 0 represents "No Pain," and 100 represents "The Worst Imaginable Pain." Patients draw a vertical line indicating their average pain over the preceding 24 hours. The distance is measured in millimeters to provide a continuous numeric value.

    Measured: Baseline (T₀, prior to the first rTMS session) and 1-Month Post-Treatment (T₂, exactly 30 days after the final rTMS session).

  2. Long-Term Durability of Analgesia via the Visual Analog Scale (VAS)

    This measure tracks the persistence of the therapeutic effect or any potential neuroplastic decay over time. It evaluates if the dual-frequency accelerated paradigm sustains a statistically valid reduction in pain scores into the third month following the intervention.

    Measured: Baseline (T₀) and 3-Months Post-Treatment (T₃, exactly 90 days after the final rTMS session).

Secondary outcomes (4)

  1. Change from Baseline in Pain Interference and Distribution via the Brief Pain Inventory

    The BPI evaluates the sensory-discriminative dimension of pain. It measures both pain intensity (worst, least, average, and current pain on a 0-10 scale) and pain interference-quantifying how much the facial pain disrupts seven functional domains of daily life (general activity, walking, mood, normal work, relationships, sleep, and enjoyment of life). It also tracks changes in the spatial distribution and trigger zones mapped on the BPI body outline chart.

    Measured: Baseline (T₀), Immediate Post-Treatment (T₁, Day 5), 1-Month Post-Treatment (T₂), and 3-Months Post-Treatment (T₃).

  2. Change from Baseline in Emotional Distress and Psychological Co-morbidities via the Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item self-rating scale used to isolate and quantify levels of anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items) triggered by prolonged exposure to chronic, severe pain. Each item is scored from 0 to 3, yielding separate subscale totals from 0 to 21. Higher scores indicate greater psychological distress (scores ≥ 11 signify severe, clinically relevant states).

    Measured: Baseline (T₀), 1-Month Post-Treatment (T₂), and 3-Months Post-Treatment (T₃).

  3. Change from Baseline in Health-Related Quality of Life via the Quality of Life Pain Scale (QoLp)

    The QoLp scale evaluates the broader functional, social, and economic toll of refractory Trigeminal Neuralgia on the patient's well-being. It measures multi-item domains including physical independence, social integration, occupational capability, and cognitive clarity under chronic pain conditions.

    Measured: Baseline (T₀), 1-Month Post-Treatment (T₂), and 3-Months Post-Treatment (T₃).

  4. Patient Global Impression of Clinical Improvement via the Patient Global Impression of Change (PGIC) Scale

    The PGIC is a single-item, 7-point categorical scale capturing the patient's holistic self-assessment of the overall shift in their medical condition since the start of the accelerated rTMS therapy. Scores range from 1 ("Very Much Improved") to 7 ("Very Much Worse"). A successful clinical response is defined as achieving a rating of 1 or 2.

    Measured: Immediate Post-Treatment (T₁, Day 5), 1-Month Post-Treatment (T₂), and 3-Months Post-Treatment (T₃).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study start23 Mar 2023
  3. Primary completion30 Mar 2026
  4. Study completion26 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07908420
Sponsor's protocol ID
LAMBEVA-16/23-Mar-2023
Other IDs
Protocol No: 16/23.03.2023
Acronym
rTMS-TN-M1
Status last verified
Oct 2026
First submitted
26 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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Questions about this trial

What is this clinical trial studying?

An observational study of Pain Management and Psychiatric Comorbidities, run by Galileo Medical Center at 1 site in Bulgaria.

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 6 inclusion and 7 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: finished, as of the sponsor's last update on 3 Nov 2026. 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 Bulgaria. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from Baseline in Patient-Reported Facial Pain Intensity via the Visual Analog Scale (VAS) (time frame: Baseline (T₀, prior to the first rTMS session) and 1-Month Post-Treatment (T₂, exactly 30 days after the final rTMS session).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07908420, which also lists 7 linked publications.

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 3 Nov 2026.

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