Recruiting

TVS & MDMA

Sponsor:

Apollo Neuroscience, Inc.

Code:

NCT05274230

Conditions

Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Apollo Wearable

Study Details

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

Study ID

NCT05274230

Start date

Dec 8, 2021

Status verified date

Jan, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Through study completion, an average of two years ]
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Through study completion, an average of two years ]

Central Contacts and Locations

Central contacts

Nicole Grinsell, MS

8559220057nicole@apolloneuro.com

Mahender Mandala, PhD

mahi@apolloneuro.com

Locations

Apollo Neuroscience, Inc.

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Nicole Grinsell, MS

855-922-0057taylor@apolloneuro.com

Mahender Mandala, PhD

mahi@apolloneuro.com

Principal Investigator:

Belinda Tan, MD PHD

More Information

Sponsor

Apollo Neuroscience, Inc.

Last update posted

Feb 2, 2023

Last verified

Jan, 2023

Keywords

  • remission
  • PTSD
  • psychotherapy
  • MDMA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Apollo Neuroscience, Inc. on 2023-02-02.