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

Apollo Neuroscience

Status: Enrolling

Conditions: Stress Disorders, Post-Traumatic

Treatments: Device: Apollo Wearable

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05274230

AN006

20214600 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

MDMA-Assisted Psychotherapy Participants

Experimental group

Description:

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.

Treatment:

Device: Apollo Wearable