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

Trial Summary

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 data supports the effectiveness of the treatment Apollo Wearable for PTSD?

Research on similar treatments, like closed-loop, allostatic neurotechnology, shows potential benefits for PTSD symptoms by improving heart rate variability and brain function. Additionally, brain stimulation devices have shown some effectiveness in treating anxiety and depression, which are related to PTSD. ^{1 2 3 4 5}

Is vibroacoustic stimulation generally safe for humans?

The research does not provide specific safety data for vibroacoustic stimulation, but it explores similar technologies for PTSD without reporting any safety concerns. ^{1 3 6 7 8}

How does vibroacoustic stimulation differ from other PTSD treatments?

Vibroacoustic stimulation is unique because it uses vibrations to potentially influence brain activity, which is different from traditional PTSD treatments that often involve medication or talk therapy. This approach is non-invasive and may target specific brain areas through controlled vibrational frequencies, offering a novel way to address PTSD symptoms. ^{9 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Belinda Tan, MD PhD

Principal Investigator

The Board of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. England 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. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Enhancing Prolonged Exposure therapy for PTSD using physiological biomarker-driven technology. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Neurofeedback with low-cost, wearable electroencephalography (EEG) reduces symptoms in chronic Post-Traumatic Stress Disorder. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Brain stimulation in posttraumatic stress disorder. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of nefazodone on subjective and objective sleep quality in posttraumatic stress disorder. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

GETSmart: Guided Education and Training via Smart Phones to Promote Resilience. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Neurotherapy of traumatic brain injury/posttraumatic stress symptoms in OEF/OIF veterans. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

A shoe insole delivering subsensory vibratory noise improves balance and gait in healthy elderly people. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Wireless Programmable Recording and Stimulation of Deep Brain Activity in Freely Moving Humans. [2021]

11. United States 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. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Finding Parameters around the Abdomen for a Vibrotactile System: Healthy and Patients with Parkinson's Disease. [2019]

13. Switzerland 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. [2023]