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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

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.
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I cannot complete questionnaires in English.

Timeline

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

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.

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Who is running the clinical trial?

The Board of MedicineUNKNOWN
3 Previous Clinical Trials
600 Total Patients Enrolled
Apollo Neuroscience, Inc.Lead Sponsor
4 Previous Clinical Trials
527 Total Patients Enrolled
Belinda Tan, MD PhDPrincipal InvestigatorThe Board of Medicine

Media Library

Apollo Wearable Clinical Trial Eligibility Overview. Trial Name: NCT05274230 — N/A
Post-Traumatic Stress Disorder Research Study Groups: MDMA-Assisted Psychotherapy Participants
Post-Traumatic Stress Disorder Clinical Trial 2023: Apollo Wearable Highlights & Side Effects. Trial Name: NCT05274230 — N/A
Apollo Wearable 2023 Treatment Timeline for Medical Study. Trial Name: NCT05274230 — N/A
~17 spots leftby Dec 2024
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