Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

EEG Biofeedback Therapy as an Adjunct Treatment for PTSD

27 ottobre 2016 aggiornato da: United States Naval Medical Center, San Diego

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

68

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • California
      • San Diego, California, Stati Uniti
        • OASIS PTSD program

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 40 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • Male,
  • active military,
  • participating in PTSD program at NMCSD

Exclusion Criteria:

  • Seizure disorder.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: EEG biofeedback
Subjects will receive EEG biofeedback according to their own brain rhythms
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.
Altri nomi:
  • EEG info device
Comparatore fittizio: sham EEG biofeedback
Subjects will receive feedback according to someone else's brain rhythms collected during a different session.
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.
Altri nomi:
  • EEG info device

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Improved Symptom Ratings
Lasso di tempo: 4 weeks
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.
4 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Julie A Onton, PhD, Naval Health Research Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2012

Completamento primario (Effettivo)

1 ottobre 2013

Completamento dello studio (Effettivo)

1 ottobre 2013

Date di iscrizione allo studio

Primo inviato

2 maggio 2012

Primo inviato che soddisfa i criteri di controllo qualità

3 maggio 2012

Primo Inserito (Stima)

4 maggio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

20 dicembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 ottobre 2016

Ultimo verificato

1 ottobre 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • NMCSD.2012.0042

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Disturbo da stress post-traumatico

Prove cliniche su EEG biofeedback

3
Sottoscrivi