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Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia

11 juni 2026 bijgewerkt door: Pulkit Grover

Transcranial Electrical Stimulation for Noninvasive Study of Pain Circuits in Patients With Chronic Pain

The goal of this interventional study is to learn whether noninvasive brain stimulation (NIBS) will have an effect on pain perception in people with fibromyalgia. The main questions it aims to answer are:

Do repeated sessions of NIBS lead to a reduction in perceived pain? Do repeated sessions of NIBS lead to an improvement in quality of life?

Researchers will compare different brain targets to see if effects are different between them.

Participants will receive repeated daily sessions of NIBS over 4 weeks with application of pressure pain algometry, and complete various questionnaires.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Participants will randomly receive primary motor cortex (M1) or occipital lobe NIBS over 2 weeks, and after a wash-out period will receive NIBS of the other target over 2 weeks. Each session will also evaluate pressure pain algometry, various questionnaires to assess changes in fibromyalgia symptoms and quality of life (up to 5 hours per session)

NIBS administration will consist of 1000 electrical pulses of <1 ms duration each.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: Benedict J Alter, PhD
  • Telefoonnummer: 412-677-0575
  • E-mail: alterbj@upmc.edu

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15206
        • UPMC Pain Management
        • Contact:
          • Benedict J Alter, MD, PhD
          • Telefoonnummer: 412-677-0575
          • E-mail: alterbj@upmc.edu
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Formal diagnosis of fibromyalgia made by a practicing physician
  • Pain resistant to common analgesics and medications for chronic pain
  • Existing pain for more than 3 months with an average of at least 4 on a 0 to 10 Numerical Rating Scale (NRS)
  • Females of child bearing potential must be at least one of the following totally abstinent from heterosexual intercourse since the last menses before start of study, or agree to concurrent use of at least two methods of birth control throughout study participation.

Exclusion Criteria:

  • If the subject is non-ambulatory.
  • If the subject is female of child-bearing potential, subject must not be pregnant.
  • Subject must not have a history of brain surgery or uncontrolled neurological conditions, such as seizure, fainting spells, transient ischemic attack.
  • Subject must not have lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease.
  • Subject must not have any implanted electronic or metallic devices.
  • Subject must not have heart diseases, including known arrhythmia, or severe liver or severe gastrointestinal disease or chronic severe infectious disease (e.g. HIV/AIDS).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Primary Motor Cortex Stimulation, then Occipital Lobe Stimulation
The primary motor cortex will be targeted first, then the occipital lobe.
Apparaat: Primary Motor Cortex Stimulation
Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the primary motor cortex (M1).
Andere namen:
  • Transcraniële elektrische stimulatie
Apparaat: Occipital Lobe Stimulation
Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the occipital lobe.
Andere namen:
  • Transcraniële elektrische stimulatie
Experimenteel: Occipital Lobe Stimulation, then Primary Motor Cortex Stimulation
The occipital lobe will be targeted first, then the primary motor cortex.
Apparaat: Primary Motor Cortex Stimulation
Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the primary motor cortex (M1).
Andere namen:
  • Transcraniële elektrische stimulatie
Apparaat: Occipital Lobe Stimulation
Short (<1 ms), high amplitude (>10 mA) noninvasive electrical pulses delivered at 1 Hz on the scalp surface. This intervention will target the occipital lobe.
Andere namen:
  • Transcraniële elektrische stimulatie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility of the transcranial electrical stimulation protocol
Tijdsspanne: From end of the last study session until up to 6 months after.
Feasibility of the protocol will be measured quantitatively using the Feasibility of Intervention Measure (FIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of feasibility. It will also be assessed qualitatively via participant interviews.
From end of the last study session until up to 6 months after.
Tolerability of transcranial electrical stimulation protocol
Tijdsspanne: Every day from enrollment until up to 6 months after the last study session.
Determined qualitatively from study-related participant attrition rate (%) and adherence to protocol (%).
Every day from enrollment until up to 6 months after the last study session.
Acceptability of transcranial electrical stimulation protocol
Tijdsspanne: From end of the last study session until up to 6 months after.
Acceptability of the protocol will be measured quantitatively using the Acceptability of Intervention Measure (AIM) score. Score ranges from 4 to 20, with higher scores indicating higher level of acceptability. It will also be assessed qualitatively via participant interviews.
From end of the last study session until up to 6 months after.
Pressure pain threshold (PPT)
Tijdsspanne: At every study session from Session 1 until the last study session.
PPT (in lbf) will be measured using a digital algometer, which will be used to press down on the participants' thumb nails and legs to assess pain sensitization throughout the study.
At every study session from Session 1 until the last study session.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Revised Fibromyalgia Impact Questionnaire (FIQR)
Tijdsspanne: Weekly from enrollment until up to 6 months after the last study session.
FIQR will be used to assess the participant's experience with fibromyalgia (symptoms and impact on daily life). Score ranges from 0 to 100, with higher scores indicating greater severity of fibromyalgia symptoms and functional impairment.
Weekly from enrollment until up to 6 months after the last study session.
Brief Pain Inventory (BPI)
Tijdsspanne: Daily, from enrollment until up to 6 months after the last study session.
BPI will be used to assess the participant's pain severity and interference. Score ranges from 0 to 10, with higher scores indicating worse (more severe) pain or interference.
Daily, from enrollment until up to 6 months after the last study session.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Tijdsspanne: Weekly, from enrollment until up to 6 months after the last study session.
We will use the standardized survey score PROMIS-29 to assess physical and mental health in seven domains (e.g., physical function, anxiety, sleep disturbance etc.). Each question score ranges from one to five, corresponding to the intensity within the question's domain. Survey scores will be converted to a t-score metric and assessed.
Weekly, from enrollment until up to 6 months after the last study session.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of steps
Tijdsspanne: Every day from enrollment until up to 4 weeks after the last study session.
Assess change in number of steps taken daily using a wearable device.
Every day from enrollment until up to 4 weeks after the last study session.
Active zone minutes
Tijdsspanne: Every day from enrollment until up to 4 weeks after the last study session.
Assess change in number of minutes spent in active heart rate zone using a wearable device.
Every day from enrollment until up to 4 weeks after the last study session.
Sleep score
Tijdsspanne: Every day from enrollment until up to 4 weeks after the last study session.
Assess change in sleep quality using a wearable device.
Every day from enrollment until up to 4 weeks after the last study session.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pulkit Grover

Medewerkers

University of Pittsburgh Clinical and Translational Science Institute (CTSI)
Department of Anesthesiology & Perioperative Medicine, University of Pittsburgh

Onderzoekers

  • Hoofdonderzoeker: Benedict J Alter, MD, PhD, University of Pittsburgh
  • Hoofdonderzoeker: Pulkit Grover, PhD, Carnegie Mellon University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

27 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 juni 2026

Eerst geplaatst (Werkelijk)

12 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

11 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY2025_00000279

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

IPD may be shared upon reasonable request to the study contacts.

IPD-tijdsbestek voor delen

Data will become available after publication per journal and funding entity protocols.

IPD-toegangscriteria voor delen

Data will be made available by reasonable request and/or per journal and funding entity protocols.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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