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

July 19, 2022 updated by: Apollo Neuroscience, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Apollo Neuro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of two years
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.
Through study completion, an average of two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of two years
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.
Through study completion, an average of two years
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
Through study completion, an average of two years
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.
Through study completion, an average of two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apollo Neuroscience, Inc.

Collaborators

The Board of Medicine

Investigators

  • Principal Investigator: Belinda Tan, MD PhD, The Board of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN006
  • 20214600 (Other Identifier: WCG IRB)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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