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Transcranial magnetic stimulation (TMS) for pain associated with chronic fatigue Syndrome/Primary fibromyalgia, long COVID and post-vaccination syndromes, post-stroke pain, and non-nociceptive pain

NCT ID NCT07888673

Sponsor: Hospital Donostia Source: ClinicalTrials.gov ↗

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Recruiting now
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Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
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Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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Status unknown
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First seen Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

47 people

The number who actually took part.

Started

Oct 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Both sexes individuals aged 18 to 75 years diagnosed of these conditions according to scheduled diagnostic and inclusion criteria. * Diagnosis of ME will be made according to 2016 Fibromyalgia diagnostic criteria (see Supplementary Appendix B, Supplemental Digital Content 1, 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome fibromyalgia long COVID-19 myalgic encephalomeyelitis/chronic fatigue syndrome Nociplastic Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pain Fibromyalgia Long COVID19 Stroke sequelae

Contacts and locations

Locations

  • Hospital Universitario de Donostia

    San Sebastián, Gipuzkoa, 20250, Spain

  • University of Balearic Islands

    Palma, Balearic Islands, 07122, Spain

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