Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder

NCT06577636 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 76919
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to test whether anesthesia-induced dreaming can help alleviate symptoms of PTSD in an (1) open-label trial (Phase I) and (2) double-blind, randomized controlled trial (Phase II) in a non-surgical setting. The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD. Participants will undergo EEG-guided propofol anesthesia during which they will be either (1) receiving deep sedation leading to loss of responsiveness, designed to elicit dream reports upon emergence (Dream Protocol), and/or (2) light sedation without loss of responsiveness, designed to elicit non-dream experiential reports while responsive (e.g., simple imagery, sounds, thoughts, bodily sensations, hypnagogic-like experiences) (Non-Dream Protocol). The investigators will then investigate whether the deep-sedation Dream Condition is associated with a larger reduction in PTSD symptoms than the light-sedation Non-Dream Condition.

Conditions

PTSD; Post-traumatic Stress Disorder

Keywords

anesthesia; propofol; PTSD; post-traumatic stress disorder; dreaming; dreams

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  The CAPS-5 is a structured interview that is considered the gold standard for assessing post-traumatic stress disorder (PTSD). The CAPS-5 is designed to assess the 20 symptoms of PTSD as defined by the DSM-5, as well as the impact of these symptoms on social and occupational functioning. The CAPS-5 includes 20 items corresponding to the DSM-5 criteria for PTSD. Each item is rated for both frequency and intensity, with a 5-point scale (0-4) for each dimension. The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. A score of \>20 points indicates clinically significant PTSD symptoms. Superiority of "Dream Experiences Group" over "Non-Dream Experiences Group" will be demonstrated by a statistically significant greater decrease in the CAPS-5 when comparing pre-anesthesia scores to post-anesthesia scores.

  1 month post-intervention

Secondary Outcomes (3)

• Number of Participants With Clinical Response

  1 month post-intervention

• Number of Participants With Remission

  1 month post-intervention

• PTSD Checklist for DSM-5 (PCL-5)

  1 month post-intervention

Study Arms (3)

Dream Experiences Group

EXPERIMENTAL

This group (n=21) will be subjected to an emergence-from-loss of responsiveness (LOR) protocol intended to elicit dream reports.

Procedure: Propofol anesthesia

Non-Dream Experiences Group

SHAM COMPARATOR

This Group (n=21) will be subjected to a light sedation without loss of responsiveness protocol, designed to elicit non-dream experiential reports while responsive.

Procedure: Propofol anesthesia

Open-label anesthesia protocol

EXPERIMENTAL

All participants (n = 15) will be subjected to an emergence-from-loss of responsiveness (LOR) protocol intended to elicit dream reports AND to a light sedation without loss of responsiveness protocol intended to elicit non-dream experiential reports while responsive.

Procedure: Propofol anesthesia

Interventions

Propofol anesthesia PROCEDURE

EEG-guided infusion of anesthestetics

Dream Experiences Group; Non-Dream Experiences Group; Open-label anesthesia protocol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 to 70 years of age
• Able to read, understand, and provide written, dated informed consent prior to screening.
• Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member and supported by the Structured Clinical Interview for DSM Disorders (SCID).
• Meet the threshold of CAPS-5 score of \>20 during screening.
• In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I or II.
• If female, a status of non-childbearing potential or use of an acceptable form of birth control
• Body mass index between 17-35 kg/m2.

You may not qualify if:

• A potential participant will NOT be eligible for participation if any of the following criteria are met:
• Female who is pregnant or breastfeeding.
• Total CAPS-5 score ≤20 at either the screening.
• Current diagnosis of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated "moderate" or "severe" per criteria of the SCID, or Alcohol Use Disorder rated "moderate" or "severe" per SCID criteria. The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated "mild"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (\>12 months) time frames.
• Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Specific Phobia, or Bipolar II Disorder (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more)
• History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
• History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.
• Any Axis I or Axis II Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening.
• In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his/her participation in the study.
• A neurological disorder
• A cardiovascular disorder
• A pulmonary/respiratory disorder
• Clinically significant liver disease
• Clinically significant kidney disease
• Symptomatic gastroesophageal reflux disease, hiatal hernia, or other gastrointestinal disorder placing patient at risk for aspiration or that would merit categorization of patient as ASA Class III or higher

Sponsors & Collaborators

• Stanford University: lead
• Tiny Blue Dot Foundation: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (3)

• Hack LM, Sikka P, Zhou K, Kawai M, Chow HS, Heifets B. Reduction in Trauma-Related Symptoms After Anesthetic-Induced Intra-Operative Dreaming. Am J Psychiatry. 2024 Jun 1;181(6):563-564. doi: 10.1176/appi.ajp.20230698. Epub 2024 Mar 13. No abstract available.

  PMID: 38476046 BACKGROUND

• Chow HS, Hack LM, Kawai M, Heifets BD. Anesthetic-Induced Intraoperative Dream Associated With Remission of a Psychiatric Disorder: A Case Report. A A Pract. 2022 Aug 10;16(8):e01613. doi: 10.1213/XAA.0000000000001613. eCollection 2022 Aug 1.

  PMID: 35952341 BACKGROUND

• Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.

  PMID: 28493729 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Boris D Heifets, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris D Heifets, MD, PhD

CONTACT

(669) 241 6118; anesthesiastudy@stanford.edu

Pilleriin Sikka, PhD

CONTACT

6506808801; sikka@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, sham-controlled RCT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Perioperative and Pain Medicine

Model Details: Two groups of participants will be randomized to either (a) Dream experiences group, or (b) Non-Dream experiences group.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: July 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will become available after the results of the study have been analyzed and published
• Access Criteria: We will share the information via Open Science Framework (osf.io), github, or via official Stanford file sharing options

Locations

US (1)