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Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05274230
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : June 30, 2022
Sponsor:
Collaborator:
The Board of Medicine
Information provided by (Responsible Party):
Apollo Neuroscience, Inc.

Tracking Information
First Submitted Date  ICMJE February 18, 2022
First Posted Date  ICMJE March 10, 2022
Last Update Posted Date June 30, 2022
Actual Study Start Date  ICMJE December 8, 2021
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2022)
  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Through study completion, an average of two years ]
    PTSD Checklist for DSM-5 (PCL-5) will be used to measure symptoms of PTSD.
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Through study completion, an average of two years ]
    Beck Depression Inventory II (BDI-II) will be used to measure symptoms of depression.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2022)
  • World Health Organization Health and Work Performance Questionnaire (HPQ Short form) [ Time Frame: Through study completion, an average of two years ]
    World Health Organization Health and Work Performance Questionnaire (HPQ Short form) will be used to measure work performance.
  • Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Through study completion, an average of two years ]
    Alcohol Use Disorders Identification Test (AUDIT) will be used to measure alcohol use.
  • Drug Use Disorders Identification Test (DUDIT) [ Time Frame: Through study completion, an average of two years ]
    Drug Use Disorders Identification Test (DUDIT) will be used to measure drug use
  • Chronic Pain Grade Scale (CPGS) [ Time Frame: Through study completion, an average of two years ]
    Chronic Pain Grade Scale (CPGS) will be used to provide a measure of symptoms of pain. The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. The 3 subscale scores (characteristic pain intensity, disability score, and the disability points score) are used to classify subjects into 1 of the 5 pain severity grades: grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
Official Title  ICMJE Sustaining Remission From Posttraumatic Stress Disorder (PTSD) Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
Brief Summary

The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation.

This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years

Detailed Description

The study examines the effect of the Apollo wearable on its users after undergoing MDMA-assisted psychotherapy. There will be no study specific modification to the MDMA-assisted psychotherapy that participants receive. All study participants will have previously consented to MAPS MDMA-assisted psychotherapy for PTSD clinical trial before enrolling in this protocol. Once they have been identified as people who have been consented to the MAPS trial regardless of this research, they will be approached about the study, and screened/consented/enrolled accordingly.

Participants will receive the Apollo wearable device via mail upon consenting to participate in this study. They will be provided an instruction manual with guidelines on how to best use the device and will be asked to continue to use the Apollo device in their everyday life following MDMA-assisted psychotherapy.

Participants in the study will be asked to complete monthly online questionnaires for the duration of the two year study.

Please note: this study is not affiliated with the MAPS organization who is running the MDMA-assisted psychotherapy research study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE Device: Apollo Wearable
Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phone. Participants will use the Apollo for at least 30 minutes after waking up in the morning and at least 30 minutes before bed on the corresponding settings for those times of day. They will be given the Apollo Device TVS (10-200 Hz) to borrow which they will be instructed to wear everyday. They will be asked to continue to wear the device until all study data is collected.
Other Name: Apollo Neuro
Study Arms  ICMJE Experimental: MDMA-Assisted Psychotherapy Participants
Participants who have completed the MDMA-Assisted Psychotherapy and consented to be part of this study will use an Apollo Device TVS (10-200 Hz) attached to the subject's wrist or ankle via a commercially available wearable vibration technology can deliver TVS (Transcutaneous Vibratory Stimulation). The intensity will be targeted for the sensory threshold (the level at which the vibration is just noticeable) as this is where the TVS seems to be most effective from prior studies. Similar vibratory stimuli have been demonstrated to be safe in the literature.10-14 The intensity of the vibration will be adjusted to the subjects' comfort and can be controlled by the subject at any time.
Intervention: Device: Apollo Wearable
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2022)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 or over
  • Completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (treatment cohort)
  • completion of the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial (placebo cohort)
  • enrolled in the MAPS MDMA-Assisted Psychotherapy for PTSD clinical trial, but dropped out

Exclusion Criteria:

  • Unable to give adequate informed consent
  • Have any current problem which, in the opinion of the investigator might interfere with participation
  • Are unable to complete questionnaires written in English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Taylor Herb, MS 7249444570 taylor@apolloneuro.com
Contact: Mahender Mandala, PhD mahi@apolloneuro.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05274230
Other Study ID Numbers  ICMJE AN006
20214600 ( Other Identifier: WCG IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Apollo Neuroscience, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Apollo Neuroscience, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Board of Medicine
Investigators  ICMJE
Principal Investigator: Belinda Tan, MD PhD The Board of Medicine
PRS Account Apollo Neuroscience, Inc.
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP