EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia. (FM-TDCS-PREDIC)
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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ane Miren Gutiérrez Muto, PhD
- 電話番号：+34960606200
- メール：investigacion@ionclinics.com
研究連絡先のバックアップ
- 名前：Ensayos Ionclincs
- 電話番号：+34674059324
- メール：ensayos@ionclinics.com
研究場所
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-
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Valencia、スペイン
- 募集
- Hospital Clínico Universitario de Valencia
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コンタクト：
- Ionclinics
- 電話番号：+34674059324
- メール：ensayos@ionclinics.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：High-dose home-tDCS M1
tDCS administered at home using a high-dose protocol targeting the primary motor cortex.
|
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). |
|
アクティブコンパレータ：Conventional home-tDCS
tDCS administered at home using a conventional stimulation protocol targeting the primary motor cortex.
|
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). |
|
実験的：High-Dose home-tDCS DLPFC
tDCS administered at home using a high-dose stimulation protocol targeting the dorsolateral prefrontal cortex.
|
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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fibromyalgia Impact Questionnaire
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
WPI
時間枠：Baseline; end of treatment (3 week experimental; 4 week active comparator)
|
Change from baseline to end of treatment in Widespread Pain Inventory (WPI).
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Baseline; end of treatment (3 week experimental; 4 week active comparator)
|
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SSS
時間枠：Baseline; end of treatment (3 week experimental; 4 week active comparator)
|
Change from baseline to end of treatment in Symptom Severity Scale (SSS).
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Baseline; end of treatment (3 week experimental; 4 week active comparator)
|
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HADS
時間枠：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).
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Baseline; end of treatment (3 week experimental; 4 week active comparator).
|
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PSQI
時間枠：Baseline; end of treatment (3 week experimental; 4 week active comparator).
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Change from baseline to end of treatment in Pittsburgh Sleep Quality Index (PSQI).
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Baseline; end of treatment (3 week experimental; 4 week active comparator).
|
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EQ-5D
時間枠：Baseline; end of treatment (3 week experimental; 4 week active comparator).
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Change from baseline to end of treatment in EuroQoL-5D (EQ-5D).
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Baseline; end of treatment (3 week experimental; 4 week active comparator).
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PGI-C
時間枠：End of treatment (3 week experimental; 4 week active comparator).
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Change at the end of treatment in Patient Global Impression of Change (PGI-C).
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End of treatment (3 week experimental; 4 week active comparator).
|
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BDI-II
時間枠：Baseline and end of treatment (week 3 for experimental; week 4 for active comparator).
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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).
|
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Resting state EEG
時間枠：Baseline
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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.
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Baseline
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
患者様の期待
時間枠：ベースライン
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1から5までのリッカート尺度（1は期待なし、5は最高の期待を意味する）を用いて、治療効果に対する期待の影響を研究する。
|
ベースライン
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Responders to tDCS
時間枠：Through study completion, an average of 2 years.
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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.
|
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Adverse Effect
時間枠：End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: 5 days per week, through 4 weeks).
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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).
|
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Success of blinding
時間枠：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
|
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Incremental Cost Effectiveness Ratio
時間枠：Through study completion, an average of 2 years.
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Incremental Cost Effectiveness Ratio (ICER) will be derived from clinical effectiveness, utility and costs.
|
Through study completion, an average of 2 years.
|
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Costs
時間枠：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.
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Utility
時間枠：Through study completion, an average of 2 years.
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Quality-adjusted life years (QALYs) will be calculated using the EQ-5D questionnaire for the cost-effectiveness analysis.
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Through study completion, an average of 2 years.
|
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NRS
時間枠：Each day during the treatment (21 days for experimental; 28 days for active comparator).
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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).
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Ane Miren Gutiérrez Muto, PhD、Ionclinics & Deionics S.L.
- スタディチェア：Mar Hernández Secorún, PhD、Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
- スタディチェア：Gustavo Sarriá Córdoba, MSc、Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ION002_EEG_TDCS_FM
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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