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Vibroacoustic Stimulation for PTSD

N/A

Recruiting

Led By Belinda Tan, MD PhD

Research Sponsored by Apollo Neuroscience, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or over

Be older than 18 years old

Must not have

Unable to give adequate informed consent

Are unable to complete questionnaires written in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of two years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if the Apollo wearable device can help people with PTSD maintain improvements in their symptoms after MDMA-assisted psychotherapy by using gentle vibrations to improve mood, energy, and focus. MDMA-assisted psychotherapy has shown effectiveness and acceptable safety in reducing PTSD symptoms.

Who is the study for?

This trial is for adults over 18 who have participated in the MAPS MDMA-Assisted Psychotherapy for PTSD study, whether they completed it or dropped out. It's not open to those who can't consent, complete English questionnaires, or have issues that may hinder participation as judged by the researcher.

What is being tested?

The study examines if a wearable device called Apollo, which emits vibrations to potentially improve mood and focus, can help sustain remission from PTSD symptoms after MDMA-assisted psychotherapy over two years.

What are the potential side effects?

While specific side effects of the Apollo wearable are not detailed here, typical concerns with wearables include skin irritation or discomfort. The safety profile will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and give consent for treatment.

Select...

I cannot complete questionnaires in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Beck Depression Inventory II (BDI-II)

PTSD Checklist for DSM-5 (PCL-5)

Secondary study objectives

Alcohol Use Disorders Identification Test (AUDIT)

Chronic Pain Grade Scale (CPGS)

Drug Use Disorders Identification Test (DUDIT)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MDMA-Assisted Psychotherapy ParticipantsExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met