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EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia. (FM-TDCS-PREDIC)

2026년 7월 13일 업데이트: Ionclinics & Deionic SL

Clinical Efficacy of tDCS in Fibromyalgia: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors.

The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with fibromyalgia.

As complementary goals, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment; and to describe the effectiveness of a high-dose home-based protocol applied to the motor cortex (M1) versus the dorsolateral prefrontal cortex (DLFPC) in patients with fibromyalgia.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

250

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 스페인
      • Valencia, 스페인
        • 모병
        • Hospital Clínico Universitario de Valencia
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Patients who meet the diagnostic criteria described by the American College of Rheumatology (Wolfe et al., 2016):
  • Widespread Pain Index (WPI) ≥7 and Symptom Severity Scale (SSS) score ≥5 or a WPI score of 4-6 and SSS ≥9
  • Presence of widespread pain, defined as pain in at least 4 of 5 regions. Jaw, chest, and abdominal pain are not included in the definition of widespread pain.
  • Symptoms have been generally present for at least 3 months.
  • The diagnosis of fibromyalgia (FM) is valid regardless of other diagnoses. The diagnosis of FM does not exclude the presence of other clinically significant diseases.
  • Patients with a stable prescription (or lack thereof) for antidepressant/pharmacological medication and who agree to continue it throughout the study.
  • Demonstrate the ability to properly administer home-based tDCS independently or with the assistance of a caregiver.
  • Have access to an electronic device with a camera (mobile phone or computer) to allow for monitoring of the intervention and communication with the participant.
  • Have the capacity and willingness to commit to the study team for the completion of all phases of the study.
  • Volunteer to participate and sign the specific informed consent form for this study.

Exclusion Criteria:

  • Presenting with immune system disorders or comorbidities that explain the main symptoms of fibromyalgia: rheumatoid arthritis, lupus, autoimmune, neurological, and oncological disorders.
  • Presenting with any uncompensated clinical condition such as ischemic heart disease, kidney disease, or liver disease.
  • Presenting with dermatological conditions, such as allergic skin reactions at the electrode sites, psoriasis, etc.
  • Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016):
  • Metallic implants or head injuries, any electronic device such as cochlear implants or cardiac pacemakers.
  • Brain stimulation within the last 6 months.
  • A clinical or family history of epilepsy.
  • Having any structural lesion (for example, any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that could affect safety, participation in the study, or confound the interpretation of the study results, as determined by the investigator.
  • History of drug or alcohol abuse during the study or in the 3 months prior (except for nicotine).
  • Changes in drug treatment in the month prior to starting the trial.
  • Awaiting trial or litigation during the trial.
  • Pregnancy

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: High-dose home-tDCS M1
tDCS administered at home using a high-dose protocol targeting the primary motor cortex.
장치: High-dose home-tDCS M1

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes.

The anode will be applied to C3 (primary motor cortex) and the cathode to Fp2 (contralateral anterior frontal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation.

Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day; (3) 3rd week - 1 time per day (total of 42 sessions).
활성 비교기: Conventional home-tDCS
tDCS administered at home using a conventional stimulation protocol targeting the primary motor cortex.
장치: Conventional home-tDCS

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes.

The anode will be applied to C3 (primary motor cortex) and the cathode to Fp2 (contralateral anterior frontal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation.

Dose: 4 weeks, from Monday to Friday. 1 time per day (total of 20 sessions).
실험적: High-Dose home-tDCS DLPFC
tDCS administered at home using a high-dose stimulation protocol targeting the dorsolateral prefrontal cortex.
장치: High-dose home-tDCS DLPFC

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes.

The anode will be applied to F3 (left dorsolateral prefrontal cortex) and the cathode to F8 (right ventrolateral prefrontal cortex). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation.

Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day; (3) 3rd week - 1 time per day (total of 42 sessions).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Fibromyalgia Impact Questionnaire
기간: Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
Changes from baseline to the end of the treatment in the revised version of Fibromyalgia Impact Questionnaire (FIQ-R).
Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).

2차 결과 측정

결과 측정
측정값 설명
기간
WPI
기간: Baseline; end of treatment (3 week experimental; 4 week active comparator)
Change from baseline to end of treatment in Widespread Pain Inventory (WPI).
Baseline; end of treatment (3 week experimental; 4 week active comparator)
SSS
기간: Baseline; end of treatment (3 week experimental; 4 week active comparator)
Change from baseline to end of treatment in Symptom Severity Scale (SSS).
Baseline; end of treatment (3 week experimental; 4 week active comparator)
HADS
기간: Baseline; end of treatment (3 week experimental; 4 week active comparator).
Change from baseline to end of treatment in Hospital Anxiety and Depression Scale (HADS).
Baseline; end of treatment (3 week experimental; 4 week active comparator).
PSQI
기간: Baseline; end of treatment (3 week experimental; 4 week active comparator).
Change from baseline to end of treatment in Pittsburgh Sleep Quality Index (PSQI).
Baseline; end of treatment (3 week experimental; 4 week active comparator).
EQ-5D
기간: Baseline; end of treatment (3 week experimental; 4 week active comparator).
Change from baseline to end of treatment in EuroQoL-5D (EQ-5D).
Baseline; end of treatment (3 week experimental; 4 week active comparator).
PGI-C
기간: End of treatment (3 week experimental; 4 week active comparator).
Change at the end of treatment in Patient Global Impression of Change (PGI-C).
End of treatment (3 week experimental; 4 week active comparator).
BDI-II
기간: Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
Changes from baseline to end of treatment in Beck Depression Inventory-II.
Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
Resting state EEG
기간: Baseline
32-channel active-electrode EEG (impedances <5 kΩ) recordings in open and close eye conditions. The spectral density and spectral power of delta, theta, alpha, beta, and gamma will be analyzed, as well as the topographic distribution.
Baseline

기타 결과 측정

결과 측정
측정값 설명
기간
환자 기대
기간: 기준선
리커트 척도 1에서 5 (1은 기대 없음, 5는 가능한 최고의 기대)를 사용하여 치료 효과에 대한 기대의 영향을 연구합니다.
기준선
Responders to tDCS
기간: Through study completion, an average of 2 years.

A subject is considered a responder if:

- Improvement of 50% or more in FIQ-R from baseline to immediate post-treatment.
Through study completion, an average of 2 years.
Adverse Effect
기간: End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: 5 days per week, through 4 weeks).
A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.
End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: 5 days per week, through 4 weeks).
Success of blinding
기간: Through study completion, an average of 2 years
A method 3 x 3 will be used to evaluate the success of the study's evaluator and statistician.
Through study completion, an average of 2 years
Incremental Cost Effectiveness Ratio
기간: Through study completion, an average of 2 years.
Incremental Cost Effectiveness Ratio (ICER) will be derived from clinical effectiveness, utility and costs.
Through study completion, an average of 2 years.
Costs
기간: Through study completion, an average of 2 years.
Direct and indirect medical and non-medical costs will be collected for the cost-effectiveness analysis.
Through study completion, an average of 2 years.
Utility
기간: Through study completion, an average of 2 years.
Quality-adjusted life years (QALYs) will be calculated using the EQ-5D questionnaire for the cost-effectiveness analysis.
Through study completion, an average of 2 years.
NRS
기간: Each day during the treatment (21 days for experimental; 28 days for active comparator).
Daily report of the numeric rating scale for symptom intensity, ranging from 0 to 10 (with 0 meaning 'none' and 10 meaning 'the worst imaginable').
Each day during the treatment (21 days for experimental; 28 days for active comparator).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ionclinics & Deionic SL

협력자

Hospital Clínico Universitario de Valencia

수사관

  • 연구 책임자: Ane Miren Gutiérrez Muto, PhD, Ionclinics & Deionics S.L.
  • 연구 의자: Mar Hernández Secorún, PhD, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
  • 연구 의자: Gustavo Sarriá Córdoba, MSc, Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 8일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2028년 6월 30일

연구 등록 날짜

최초 제출

2026년 4월 30일

QC 기준을 충족하는 최초 제출

2026년 5월 7일

처음 게시됨 (실제)

2026년 5월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ION002_EEG_TDCS_FM

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

In accordance with the recommendations of the International Committee of Medical Journal Editors, the de-identified individual participant data (IPD) that underlie the results reported in this study will be shared. The data will become accessible one year after the publication of the primary results and will remain available for five years. Access will be provided to researchers who inquire and agree to a data-use agreement through Ionclinics (investigacion@ionclinics.com/ensayos@ionclinics.com). The data will be de-identified and shared in accordance with applicable regulations and the informed consent provided by the participants.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다