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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of two years
Awards & highlights

Study Summary

This trial will test whether the Apollo wearable, which emits gentle vibrations, can help improve symptoms of PTSD following MDMA-assisted psychotherapy.

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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Beck Depression Inventory II (BDI-II)
PTSD Checklist for DSM-5 (PCL-5)
Secondary outcome measures
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
6,530 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for this clinical trial's participants?

"Affirmative. According to clinicaltrials.gov, this research initiative is recruiting individuals and first appeared on December 8th 2021 with the most recent update occurring on July 19th 2022. 200 study participants are being sought out at a single medical centre."

Answered by AI

What aims are investigators attempting to accomplish with this research?

"Apollo Neuroscience, Inc., the sponsor of this trial, seeks to evaluate Beck Depression Inventory II (BDI-II) scores over an average two year period as their primary outcome. Moreover, Drug Use Disorders Identification Test (DUDIT), Alcohol Use Disorders Identification Test (AUDIT), and Chronic pain Grade Scale (CPGS) will be used to assess secondary outcomes such as drug use frequency, alcohol consumption levels, and chronic pain severity respectively. CPGS is composed of three subscale measurements that assign subjects into one of five grades ranging from no pain to severely limiting pain intensity and disability."

Answered by AI

How many participants will this research project admit?

"Affirmative. According to the information present on clinicaltrials.gov, this research endeavor is recruiting participants with vigor; it was first announced on December 8th 2021 and was most recently updated July 19th 2022. 200 individuals need to be recruited from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
California
Pennsylvania
Maryland
Other
How old are they?
18 - 65
What site did they apply to?
Apollo Neuroscience, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Interest in cPTSD and other trauma trials. I have DID.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
2021. "Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05274230.
All > Post Traumatic Stress Disorder > Ptsd
~44 spots leftby Dec 2024
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