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

Not Applicable

Recruiting

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Device: Apollo Wearable

• Registration Number: NCT05274230
• Lead Sponsor: Apollo Neuroscience, Inc.

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 Timeline

• Study Start: 2021-12-08
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDMA-Assisted Psychotherapy Participants	Apollo Wearable	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.

Primary Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-5 (PCL-5)	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)	Through study completion, an average of two years	Beck Depression Inventory II (BDI-II) will be used to measure symptoms of depression.

Secondary Outcome Measures

Name	Time	Method
Alcohol Use Disorders Identification Test (AUDIT)	Through study completion, an average of two years	Alcohol Use Disorders Identification Test (AUDIT) will be used to measure alcohol use.
World Health Organization Health and Work Performance Questionnaire (HPQ Short form)	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.
Drug Use Disorders Identification Test (DUDIT)	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)	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.

Trial Locations

Locations (1)

Apollo Neuroscience, Inc.; 🇺🇸 Pittsburgh, Pennsylvania, United States