EEG Biofeedback Therapy as an Adjunct Treatment for PTSD
Placebo-controlled Study of EEG Biofeedback Therapy as an Adjunct Treatment for PTSD, Evaluating Symptoms and EEG Dynamics
The proposed study, "Placebo-controlled study of EEG biofeedback therapy as an adjunct treatment for PTSD, evaluating symptoms and EEG dynamics", will investigate the brain dynamics associated with PTSD symptom reduction associated with EEG biofeedback therapy or sham EEG biofeedback in addition to treatment as usual at the Naval Medical Center, San Diego (NMCSD) OASIS program.
EEG biofeedback treatment protocols for PTSD and other disorders have been developed and honed by private practice clinicians over the past 25 years, during which EEG biofeedback has become an increasingly popular adjunct therapy.
The reported success of EEG biofeedback as a non-drug intervention with lasting efficacy warrants a clinical study investigating not only symptom reduction, but also the underlying neurobiological mechanism. To this end, we propose a study using high density EEG recordings before and after treatment for PTSD symptoms to determine which brain activities correlate with reported symptom changes.
The proposed study could expand treatment alternatives for servicemen with PTSD. If EEG biofeedback is shown to improve symptom reduction over the placebo controlled condition, it would offer a non-pharmacological intervention that would avoid undesirable side effects, and accelerate recovery compared with the current standard of care.
調査の概要
詳細な説明
EEG biofeedback is an emerging alternative approach to treating PTSD, for which there is still insufficient evidence to assume unequivocal clinical utility. However, a 1991 report showed PTSD symptom reduction in 14 subjects receiving EEG biofeedback, as compared to 13 subjects receiving traditional treatment (Peniston, 1991), and a recent case study of 2 PTSD patients receiving EEG biofeedback therapy also showed reduce symptom severity using a newer protocol and device (Othmer, 2009). Another recent study focused on the anxiety symptoms of PTSD and showed that EEG biofeedback significantly reduced anxiety compared to subjects not receiving treatment (Walker, 2009).
EEG biofeedback has also been explored as a treatment for non-PTSD related anxiety disorders, with results showing significant changes in reported anxiety correlated with increased or decreased alpha-frequency (~8-12 Hz) power (Hardt, 1978). Similarly, alpha-frequency EEG biofeedback has been shown to reduce anxiety and to reduce heart rate reactivity to a stressor after 8 sessions of EEG biofeedback training (Rice, 1993). While EEG biofeedback has been shown to significantly change EEG power dynamics (Egner, 2004), it is still unclear if and how EEG biofeedback can effect long-term and complex changes in cognitive and/or emotional functioning.
Some attention has been given to other types of biofeedback for the treatment for PTSD, such as heart rate variability (HRV) biofeedback, which may be relevant in understanding the background of biofeedback with respect to PTSD treatment. While one study reported no difference in symptom reduction between treatment as usual and treatment as usual plus HRV biofeedback (Lande, 2010), a handful of other studies have reported significant associations between HRV changes and PTSD symptoms. Specifically, increased HRV was significantly correlated with PTSD symptom reduction, which was more effective with respiratory sinus arrhythmia (RSA) (which affects HRV) biofeedback than with progressive muscle relaxation (Zucker, 2009). Furthermore, combat-related PTSD subjects showed lower resting HRV than controls, but training with HRV biofeedback increased PTSD subjects' HRV and simultaneously decreased their PTSD symptoms (Tan, 2011). Finally, a quantitative EEG study showed that an acute session of RSA biofeedback was associated with an increase in alpha-band power and reduced higher frequency beta-band power, suggesting a neural impact of RSA training and HRV regulation (Sherlin, 2010).
Summary The proposed study of EEG biofeedback at the OASIS program will not only address the clinical efficacy, but also the brain activations associated with specific symptoms of PTSD through collection of high-density EEG data before and after EEG biofeedback treatment. These data will help elucidate the neural correlates of PTSD symptom expression as well as address the potential efficacy of EEG biofeedback therapy as an adjunct treatment for PTSD-like symptoms.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Diego、California、アメリカ
- OASIS PTSD program
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male,
- active military,
- participating in PTSD program at NMCSD
Exclusion Criteria:
- Seizure disorder.
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:EEG biofeedback
Subjects will receive EEG biofeedback according to their own brain rhythms
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EEG data is collected from the scalp.
Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.
他の名前:
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偽コンパレータ:sham EEG biofeedback
Subjects will receive feedback according to someone else's brain rhythms collected during a different session.
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EEG data is collected from the scalp.
Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.
他の名前:
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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 |
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Improved Symptom Ratings
時間枠:4 weeks
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Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback.
The scale for each rating was a 0-10, with 0 meaning "not at all" and 10 being "extremely" anxious/irritable.
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4 weeks
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協力者と研究者
捜査官
- 主任研究者:Julie A Onton, PhD、Naval Health Research Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
キーワード
その他の研究ID番号
- NMCSD.2012.0042
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?
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
PTSDの臨床試験
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Imperial College Healthcare NHS TrustImperial College London募集
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VA Office of Research and DevelopmentUniversity of California, San Diego募集
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University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)積極的、募集していない
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Oregon Health and Science University招待による登録
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VA Office of Research and DevelopmentPortland VA Medical Center積極的、募集していない
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VA Office of Research and DevelopmentSan Diego Veterans Healthcare System完了
EEG biofeedbackの臨床試験
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Radboud University Medical Center完了
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University of Massachusetts, WorcesterNational Center for Complementary and Integrative Health (NCCIH)完了
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Bio-Signal Group Corp.National Institute of Neurological Disorders and Stroke (NINDS); State University of New York... と他の協力者完了
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L. Eugene ArnoldNational Institute of Mental Health (NIMH); Brain Resource Center完了
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Tel-Aviv Sourasky Medical Centerわからない
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Children's Hospital of PhiladelphiaMasimo Corporation募集
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Baptist Health South FloridaFlorida International University引きこもった