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

11. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

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

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
      • Pittsburgh, Pennsylvania, Forenede Stater, 15206
        • UPMC Pain Management
        • Kontakt:
          • Benedict J Alter, MD, PhD
          • Telefonnummer: 412-677-0575
          • E-mail: alterbj@upmc.edu
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Primary Motor Cortex Stimulation, then Occipital Lobe Stimulation
The primary motor cortex will be targeted first, then the occipital lobe.
Enhed: 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).
Andre navne:
  • Transcranial elektrisk stimulering
Enhed: 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.
Andre navne:
  • Transcranial elektrisk stimulering
Eksperimentel: Occipital Lobe Stimulation, then Primary Motor Cortex Stimulation
The occipital lobe will be targeted first, then the primary motor cortex.
Enhed: 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).
Andre navne:
  • Transcranial elektrisk stimulering
Enhed: 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.
Andre navne:
  • Transcranial elektrisk stimulering

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of the transcranial electrical stimulation protocol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Revised Fibromyalgia Impact Questionnaire (FIQR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of steps
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pulkit Grover

Samarbejdspartnere

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

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY2025_00000279

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Kliniske forsøg med Fibromyalgi (FM)

Kliniske forsøg med Primary Motor Cortex Stimulation

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