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

NCT05274230 | Unknown

• 2 other identifiers: AN00620214600
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Stress Disorders, Post-Traumatic

Keywords

remission; PTSD; psychotherapy; MDMA

Outcome Measures

Primary Outcomes (2)

• PTSD Checklist for DSM-5 (PCL-5)

  PTSD Checklist for DSM-5 (PCL-5) will be used to measure symptoms of PTSD.

  Through study completion, an average of two years

• Beck Depression Inventory II (BDI-II)

  Beck Depression Inventory II (BDI-II) will be used to measure symptoms of depression.

  Through study completion, an average of two years

Secondary Outcomes (4)

• World Health Organization Health and Work Performance Questionnaire (HPQ Short form)

  Through study completion, an average of two years

• Alcohol Use Disorders Identification Test (AUDIT)

  Through study completion, an average of two years

• Drug Use Disorders Identification Test (DUDIT)

  Through study completion, an average of two years

• Chronic Pain Grade Scale (CPGS)

  Through study completion, an average of two years

Study Arms (1)

MDMA-Assisted Psychotherapy Participants

EXPERIMENTAL

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.

Device: Apollo Wearable

Interventions

Apollo Wearable DEVICE

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.

Also known as: Apollo Neuro

MDMA-Assisted Psychotherapy Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Apollo Neuroscience, Inc.: lead
• The Board of Medicine: collaborator

Study Sites (1)

Apollo Neuroscience, Inc.

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

Related Links

• Participants who are interested in the study can use the screener link to verify their eligibility

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Belinda Tan, MD PhD

  The Board of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Grinsell, MS

CONTACT

8559220057; nicole@apolloneuro.com

Mahender Mandala, PhD

CONTACT

mahi@apolloneuro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 10, 2022
• Study Start: December 8, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

US (1)