Transcraneal Magnetic Stimulation for Treatment of Non-nociceptive Pain in Chronic Diseases

NCT07888673 | Completed

• 1 other identifier: PS2025054
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Chronic non-nociceptive or nociplastic pain and neurological sequelae following stroke are associated with substantial functional impairment and reduced quality of life. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique capable of modulating cortical excitability and functional brain networks involved in pain processing and neurological recovery. However, its clinical response may vary according to the underlying phenotype and therapeutic target. Objective: To evaluate the safety, tolerability, and clinical response to rTMS as a complementary therapeutic intervention in patients with chronic non-nociceptive pain, fibromyalgia, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), Long COVID, and post-stroke sequelae, and to explore differences in treatment response across clinical conditions. Methods: A clinical study including baseline assessment, rTMS intervention, post-treatment evaluation, and follow-up was conducted. The protocol consisted of ten treatment sessions administered over two consecutive weeks. For chronic pain, fibromyalgia, ME/CFS, and Long COVID, excitatory stimulation at 10 Hz was delivered over the left primary motor cortex (M1), with 1,000 pulses per session. For post-stroke sequelae, inhibitory stimulation at 1 Hz with 600 pulses was applied according to the predominant clinical deficit. Target localization was performed using neuronavigation when individual magnetic resonance imaging was available and the international 10-20 system when it was not. Clinical outcomes included pain, fatigue, sleep, quality of life, motor function, and language performance, assessed using validated clinical scales.

Conditions

Stroke Sequelae; Chronic Pain; Fibromyalgia; Long COVID19

Keywords

repetitive transcranial magnetic stimulation; nociplastic pain; fibromyalgia; chronic fatigue syndrome

Outcome Measures

Primary Outcomes (1)

• Number of adverse effects

  Safety and adverse effects

  1 year

Secondary Outcomes (8)

• Visual Analogue Scale (VAS)

  1 year

• Fatigue Assessment Scale (FAS)

  1 year

• Fibromyalgia Impact Questionnaire (FIQ)

  1 year

• Fugl-Meyer Assessment (FMA)

  1 year

• Boston Diagnostic Aphasia Examination (BDAE)

  1 year

Study Arms (2)

Control group

NO INTERVENTION

Active and control group . Active group received treatment. Control group did not received treatment

Active group

EXPERIMENTAL

TMS

Device: Transcraneal Magnetic Stimulation (rTMS)

Interventions

Transcraneal Magnetic Stimulation (rTMS) DEVICE

Applied transcraneal magnetic stimulation

Active group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ME will be made according to 2016 Fibromyalgia diagnostic criteria (see Supplementary Appendix B, Supplemental Digital Content
• , https://links.lww.com/PHM/B78 ).
• Patients with ME should have an score of 4/10 or greater in visual analog scale-pain and under stable treatment (any kind of treatment including pharmacotherapy, physical therapy, psychotherapy, interventional pain treatments) for at least last 3 months.
• Hemi paresis due to stroke, with diagnostic criteria for cerebral infarction and cerebral haemorrhage, confirmed by cranial CT or MRI affecting unilateral cerebral hemisphere;
• Stable vital signs, clear consciousness, and willingness to cooperate.

You may not qualify if:

• History of seizures (epilepsy)
• Metallic (foreign or implanted) objects in the skull or soft cranial tissues.
• Pronounced tattoos in the region of the head.
• Implanted deep brain stimulators or other intracranial implants.
• Cardiac pacemaker or defibrilator
• Other serious physical illness and other psychiatric comorbidities beside major depression and borderline personality disorder.
• Moreover, patients with acute suicidality (MADRS score \> 4 for question 10)
• Tinnitus, pregnancy, claustrophobia, current or previous treatment with electroconvulsive therapy or vagus nerve stimulation are not eligible.
• Patients taking anti-epileptic medication including will be also excluded as well as, patients under legal guardianship with reservation of consent.

Sponsors & Collaborators

• Hospital Donostia: lead

Study Sites (2)

University of Balearic Islands

Palma, Balearic Islands, 07122, Spain

Location

Hospital Universitario de Donostia

San Sebastián, Gipuzkoa, 20250, Spain

Location

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia; Post-Acute COVID-19 Syndrome; Nociplastic Pain; Fatigue Syndrome, Chronic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Encephalomyelitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Oznur Buran Sevik, MD

  Donostia University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: October 22, 2026
• Study Start: October 1, 2025
• Primary Completion: May 2, 2026
• Study Completion: June 1, 2026
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)