Stress Disorders, Post-TraumaticNCT05274230
Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
A study testing Apollo Wearable in people with Stress Disorders, Post-Traumatic, run by Apollo Neuroscience, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Apollo Wearable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mahender Mandala, PhD contact
United States1 site, 1 recruiting
- Recruiting
Apollo Neuroscience, Inc.
Pittsburgh, Pennsylvania, 15219
Nicole Grinsell, MS, 855-922-0057, taylor@apolloneuro.com
Mahender Mandala, PhD, mahi@apolloneuro.com
About this study
Official title: 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
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Apollo Wearable
- Keywords
- remission, PTSD, psychotherapy, MDMA
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo WearableDevice
Also called Apollo Neuro
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.
| Study group | Role | What they receive |
|---|---|---|
| MDMA-Assisted Psychotherapy Participants | Experimental | 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. Receives: Device: Apollo Wearable |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
PTSD Checklist for DSM-5 (PCL-5) will be used to measure symptoms of PTSD.
Measured: Through study completion, an average of two years
Beck Depression Inventory II (BDI-II)
Beck Depression Inventory II (BDI-II) will be used to measure symptoms of depression.
Measured: Through study completion, an average of two years
Secondary outcomes (4)
World Health Organization Health and Work Performance Questionnaire (HPQ Short form)
World Health Organization Health and Work Performance Questionnaire (HPQ Short form) will be used to measure work performance.
Measured: Through study completion, an average of two years
Alcohol Use Disorders Identification Test (AUDIT)
Alcohol Use Disorders Identification Test (AUDIT) will be used to measure alcohol use.
Measured: Through study completion, an average of two years
Drug Use Disorders Identification Test (DUDIT)
Drug Use Disorders Identification Test (DUDIT) will be used to measure drug use
Measured: Through study completion, an average of two years
Chronic Pain Grade Scale (CPGS)
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.
Measured: Through study completion, an average of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start8 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apollo Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Board of Medicine
- Responsible party
- Sponsor
- Investigators
- Belinda Tan, MD PhD, Principal investigator, The Board of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274230
- Sponsor's protocol ID
- AN006
- Other IDs
- 20214600
- Status last verified
- Jan 2023
- First submitted
- 18 Feb 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustaining Remission From Posttraumatic Stress Disorder (PTSD) Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy
- ClinicalTrials.gov ID
- NCT05274230
- Acronym / sponsor ID
- AN006
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- remission, PTSD, psychotherapy, MDMA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Apollo Neuroscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Board of Medicine
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group study. All participants will receive identical instructions regarding the device and will complete the same survey measures.
| Arm | Type | Receives |
|---|---|---|
| MDMA-Assisted Psychotherapy Participants | Experimental | Device: Apollo WearableParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apollo WearableAlso: Apollo NeuroParticipants 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. | Device | MDMA-Assisted Psychotherapy Participants |
Primary outcome
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.
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.
4 secondary outcomes
World Health Organization Health and Work Performance Questionnaire (HPQ Short form)
Time frame: Through study completion, an average of two years
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Through study completion, an average of two years
Drug Use Disorders Identification Test (DUDIT)
Time frame: Through study completion, an average of two years
Chronic Pain Grade Scale (CPGS)
Time frame: Through study completion, an average of two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Participants who are interested in the study can use the screener link to verify their eligibilityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahender Mandala, PhD contact
Belinda Tan, MD PhD principal investigator
The Board of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo Wearable in people with Stress Disorders, Post-Traumatic, run by Apollo Neuroscience, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Grinsell, MS (8559220057, nicole@apolloneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Through study completion, an average of two years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.