Vibroacoustic Stimulation for PTSD

Overseen By Belinda Tan, MD PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Apollo Neuroscience, Inc.

Disqualifiers: Inadequate consent, English comprehension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a wearable device called Apollo, which emits gentle vibrations that may improve mood, energy, and focus. The goal is to determine if regular use of Apollo can enhance the benefits of MDMA-assisted psychotherapy for PTSD, specifically targeting depression, anxiety, and emotional control. Participants should have previously participated in MDMA-assisted psychotherapy for PTSD, regardless of completion. As an unphased trial, this study offers a unique opportunity to explore innovative methods to improve mental health and well-being.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Apollo wearable device is safe for use in PTSD treatment?

Research has shown that the Apollo wearable device, which emits gentle vibrations, has been well-received in several studies. These studies indicate that the device can enhance mood, energy, and focus, with no serious safety concerns reported. In one study, users experienced a significant reduction in stress levels and improvements in sleep, energy, and mood. The device has also undergone thorough testing to ensure its safety and effectiveness in improving heart rate variability, a measure of stress. Overall, these findings suggest that the Apollo wearable is safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the Apollo Wearable for PTSD because it leverages a novel delivery method called Transcutaneous Vibratory Stimulation (TVS). Unlike traditional treatments such as medication or talk therapy, this wearable device administers gentle vibrations directly to the skin, potentially offering a non-invasive alternative with fewer side effects. The vibrations are tailored to the sensory threshold, making them both effective and adjustable for comfort. This innovative approach could provide quicker relief and greater convenience for those struggling with PTSD.

What evidence suggests that the Apollo wearable is effective for PTSD?

Research shows that the Apollo wearable device, used by participants in this trial, might help people with PTSD through gentle vibrations. These vibrations boost mood, energy, and focus. In a previous study, users of the Apollo device reported a significant drop in stress levels, with some experiencing up to a 40% decrease in stress scores. Many people also use the device to aid relaxation, focus, and sleep. The Apollo wearable likely works by improving heart rate variability (HRV), which indicates lower stress. While more research is needed, early results are promising for those dealing with PTSD. ^{1 3 5 6 7}

Who Is on the Research Team?

Belinda Tan, MD PhD

Principal Investigator

The Board of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am unable to understand and give consent for treatment.

I cannot complete questionnaires in English.

Have any current problem which, in the opinion of the investigator might interfere with participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Apollo wearable device following MDMA-assisted psychotherapy

2 years

Monthly online questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Apollo Wearable

Trial Overview 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.

How Is the Trial Designed?

Group I: MDMA-Assisted Psychotherapy Participants Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Apollo Neuroscience, Inc.

Lead Sponsor

Trials

5

Recruited

730+

The Board of Medicine

Collaborator

Trials

3

Recruited

600+

The Board of Medicine

Collaborator

Trials

4

Recruited

800+

Published Research Related to This Trial

In a pilot study involving 19 participants with self-reported PTSD symptoms, 89% reported clinically significant reductions in their symptoms after using a closed-loop neurotechnology over a median of 16 sessions.

The intervention also led to significant improvements in heart rate variability and baroreflex sensitivity, indicating potential physiological benefits, with no reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical, hemispheric, and autonomic changes associated with use of closed-loop, allostatic neurotechnology by a case series of individuals with self-reported symptoms of post-traumatic stress. Tegeler, CH., Cook, JF., Tegeler, CL., et al.[2022]

Prolonged Exposure (PE) therapy is a highly effective treatment for PTSD, and this study introduces a new technology that allows therapists to guide patients through in vivo exposures (IVEs) in real-time, enhancing the treatment process.

The study involves a pilot randomized clinical trial with 40 veterans to assess the feasibility and preliminary efficacy of this innovative system, which collects physiological and self-report data to optimize exposure therapy and potentially improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Prolonged Exposure therapy for PTSD using physiological biomarker-driven technology. Back, SE., Acierno, R., Saraiya, TC., et al.[2023]

The Flexyx Neurotherapy System (FNS) was tested on seven treatment-refractory veterans from the Afghanistan/Iraq wars, showing significant reductions in neurobehavioral and posttraumatic stress symptoms.

FNS appears to be a promising intervention for veterans suffering from mixed trauma spectrum syndromes, suggesting its potential efficacy in treating complex psychological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurotherapy of traumatic brain injury/posttraumatic stress symptoms in OEF/OIF veterans. Nelson, DV., Esty, ML.[2013]

In a study involving 18 service members and veterans with military-related post-traumatic stress (PTS), the use of HIRREM® neurotechnology resulted in significant reductions in symptoms of PTS, insomnia, depression, and anxiety, with effects lasting up to 6 months after treatment.

The intervention also led to notable improvements in heart rate variability and baroreflex sensitivity, indicating enhanced autonomic cardiovascular regulation, with no reported adverse events, suggesting it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful use of closed-loop allostatic neurotechnology for post-traumatic stress symptoms in military personnel: self-reported and autonomic improvements. Tegeler, CL., Gerdes, L., Shaltout, HA., et al.[2018]

Neurofeedback training using low-cost EEG technology showed significant effectiveness in reducing PTSD symptoms among participants in Rwanda, with clinically relevant improvements observed in three different measures of symptom severity.

The study found that neurofeedback led to an increase in resting-state alpha brain activity, known as 'alpha rebound', which was not seen in the motor-imagery group, highlighting the unique mechanism of action for neurofeedback in promoting self-regulation of brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback with low-cost, wearable electroencephalography (EEG) reduces symptoms in chronic Post-Traumatic Stress Disorder. du Bois, N., Bigirimana, AD., Korik, A., et al.[2021]

A study involving 12 healthy elderly participants demonstrated that subsensory vibratory noise from piezoelectric insoles significantly improved balance and gait, as evidenced by better performance on the Timed Up and Go (TUG) test and reduced postural sway.

The effective vibratory noise levels were found to be between 70% and 85% of the sensory threshold, and these improvements in balance and gait were consistent throughout the day, indicating a stable sensory response to the stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A shoe insole delivering subsensory vibratory noise improves balance and gait in healthy elderly people. Lipsitz, LA., Lough, M., Niemi, J., et al.[2022]

In a 12-week study involving 10 Vietnam combat veterans with chronic PTSD, nefazodone treatment significantly reduced PTSD and depressive symptoms, indicating its efficacy as a therapeutic option.

Nefazodone also improved both subjective and objective sleep quality, leading to longer total sleep time and better sleep maintenance, which is crucial for veterans suffering from sleep disturbances related to PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of nefazodone on subjective and objective sleep quality in posttraumatic stress disorder. Neylan, TC., Lenoci, M., Maglione, ML., et al.[2019]

A smartphone-based intervention program for military service members with subthreshold PTSD symptoms showed significant reductions in PTSD Checklist scores from baseline to post-intervention, with effects maintained at a 3-month follow-up.

The program, which included a Skype session and daily text messages guiding app use, was found to be feasible and acceptable to participants, indicating potential for broader application in addressing PTSD symptoms in military populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GETSmart: Guided Education and Training via Smart Phones to Promote Resilience. Roy, MJ., Highland, KB., Costanzo, MA.[2022]

Brain stimulation devices, including both traditional methods like Electroconvulsive Therapy (ECT) and newer techniques like Transcranial Magnetic Stimulation (TMS) and Vagus Nerve Stimulation (VNS), show promise in addressing PTSD symptoms, particularly in reducing associated anxiety and depression.

Current evidence suggests that while ECT may help with comorbid depression in PTSD patients, it does not significantly improve core PTSD symptoms, highlighting the need for more targeted research and novel treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain stimulation in posttraumatic stress disorder. Novakovic, V., Sher, L., Lapidus, KA., et al.[2022]

The Mo-DBRS platform allows for wireless and programmable recording and stimulation of deep brain activity, making it a versatile tool for studying natural human behavior in real-world settings.

By integrating with VR/AR and wearable sensors, this platform enhances the ability to investigate the neural mechanisms of behavior and develop therapies for neurological and psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless Programmable Recording and Stimulation of Deep Brain Activity in Freely Moving Humans. Topalovic, U., Aghajan, ZM., Villaroman, D., et al.[2021]

This study introduces a novel method using targeted subcutaneous vibration and in vivo electrophysiological recordings to investigate how whole body vibration affects the central nervous system, specifically GABA neuron activity in the brain.

Results indicate that peripheral vibration can significantly influence GABA neuron firing rates in a way that depends on both the frequency and location of the vibration, highlighting the need for standardized methods in vibrational therapy research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Subcutaneous Vibration With Single-Neuron Electrophysiology As a Novel Method for Understanding the Central Effects of Peripheral Vibrational Therapy in a Rodent Model. Bills, KB., Clarke, T., Major, GH., et al.[2020]

A study involving 15 healthy individuals and 15 patients with Parkinson's Disease identified a threshold frequency of 180 Hz and a minimum vibration perception interval of 250 ms for effective vibrotactile feedback.

These findings will inform the design of a wearable biofeedback device aimed at helping Parkinson's patients overcome Freezing of Gait (FOG), a common and disabling symptom of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding Parameters around the Abdomen for a Vibrotactile System: Healthy and Patients with Parkinson's Disease. Gonçalves, H., Moreira, R., Rodrigues, A., et al.[2019]

A new non-invasive treatment called vibrotactile coordinated reset (vCR) aims to improve motor and non-motor symptoms in Parkinson's disease (PD) patients by delivering gentle vibrations to the fingertips, with a 7-month study involving 30 participants to assess its efficacy.

The study will measure the effects of vCR on motor abilities using the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and other evaluations, with the goal of providing evidence for FDA clearance of this innovative therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. Pfeifer, KJ., Cook, AJ., Yankulova, JK., et al.[2023]

Citations

1. neuro-central.com neuro-central.com/apollo-neuroscience-initiates-irb-approved-clinical-trial-series-to-understand-effectiveness-of-the-apollo-wearable-for-treatment-of-ptsd/

Apollo Neuroscience Initiates IRB-Approved Clinical Trial ... The Apollo wearable has been tested in multiple studies and clinical trials and is proven to improve heart rate variability (HRV), a key biometric of stress ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05274230

NCT05274230 | Sustaining Remission From PTSD Using ... 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 ...

3. apolloneuro.com apolloneuro.com/pages/apollo-neuro-research?srsltid=AfmBOori6sfCG3fE6rqTPJq35dfGisoHq5r07vVIRDoRNn0muaWjax5_

Apollo Neuro Research Statistically significant results were observed. Open-label trial of Apollo to improve symptoms in patients with PTSD ... Primary outcome. Mood & behavior, stress ...

4. apolloneuro.com apolloneuro.com/en-intl/blogs/research/real-world-ptsd-study-is-complete?srsltid=AfmBOoqSA-oD5o0heuCBTfmrqY1r6IKYCfCSPi8hzU__To3R9HshuC7b

Apollo Neuro real-world PTSD study is complete The Apollo wearable is currently being used by tens of thousands of people to aid in stress relief, for more relaxation, focus, and sleep. The ...

5. health.harvard.edu health.harvard.edu/blog/harvard-health-ad-watch-can-a-wearable-device-reduce-stress-202109222601

Harvard Health Ad Watch: Can a wearable device reduce ... For 11 nurses using the Apollo Neuro, average stress scores fell by more than 40% within two weeks, and sleep, energy, mood, focus, and stress ...

6. apolloneuro.com apolloneuro.com/pages/apollo-neuro-research?srsltid=AfmBOopSvy-kydJ12P28D9nw456TBN5ABcK49gzW6x3YTNThEg9giD5d

Apollo Neuro Research The Apollo technology's efficacy and safety have been validated in over a dozen independent and university-led trials, and there are more studies in ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395625005552

The effect of the Apollo Neuro device on anxiety among ... The Apollo wearable device (wrist or ankle) is an investigational device which provides touch therapy with silent vibrations that may help individuals ...