Vagus Nerve Stimulation + PEPC for Fibromyalgia and PTSD
(SWIFT-RELIEVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a device for stimulating the vagus nerve (Transauricular Vagus Nerve Stimulation, or taVNS) can help manage pain and improve PTSD symptoms. The study compares two groups: one receiving active nerve stimulation and another receiving a sham version, both paired with PTSD therapy sessions (Prolonged Exposure in Primary Care, or PE-PC). It specifically seeks Veterans who experience both fibromyalgia (a condition causing widespread pain) and PTSD. Participants should have experienced fibromyalgia pain for at least three months and ongoing PTSD symptoms. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative treatments for managing fibromyalgia and PTSD symptoms.
What prior data suggests that this device is safe for pain management in Veterans with fibromyalgia and PTSD?
Research has shown that transauricular Vagus Nerve Stimulation (taVNS) is generally safe for people. Studies have found it to be well-tolerated, with only mild and short-lived side effects. Some individuals might experience slight ear pain, but it usually resolves quickly. This non-invasive treatment, which does not involve surgery, has been safely used for conditions like chronic pain and mood disorders. This suggests it could be a safer choice compared to surgical treatments. Overall, taVNS has a good safety record based on current research.12345
Why are researchers excited about this trial?
Most treatments for fibromyalgia and PTSD typically involve medications like antidepressants, pain relievers, and therapy sessions. But transauricular Vagus Nerve Stimulation (taVNS) offers a unique approach. Unlike traditional methods, taVNS directly stimulates the vagus nerve through the ear, potentially impacting brain areas involved in mood and pain regulation. This novel delivery method could offer more targeted relief with fewer side effects. Researchers are excited about this method because it combines taVNS with a specialized psychotherapy called Processing Emotions in Primary Care (PEPC), which may enhance treatment effectiveness for both conditions.
What evidence suggests that this device is effective for fibromyalgia and PTSD?
Research has shown that stimulating the vagus nerve through the ear (taVNS) yields promising results for various conditions. For example, one study found that taVNS significantly reduced knee pain shortly after treatment. In this trial, participants in the taVNS plus PEPC arm will receive transauricular vagus nerve stimulation combined with brief PTSD psychotherapy. Specifically, stimulating the vagus nerve has improved PTSD symptoms, with benefits lasting for months. Another study found that taVNS can also help reduce anxiety and improve sleep quality. Overall, these findings suggest that taVNS could effectively manage pain and PTSD symptoms.678910
Who Is on the Research Team?
Anna Woodbury, MD
Principal Investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
Sheila A.M. Rauch, PhD
Principal Investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
Are You a Good Fit for This Trial?
This trial is for English-speaking Veterans with both fibromyalgia and PTSD, confirmed by specific questionnaires and pain scores. Participants must have stable medication use, not be pregnant or breastfeeding, and cannot have severe mental health issues, recent substance abuse, or other major medical problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either active or sham transauricular vagus nerve stimulation (taVNS) combined with Prolonged Exposure in Primary Care (PE-PC) for 4 weeks
Open-label extension
Participants may opt into continuation of active taVNS treatment for an additional 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of pain and PTSD symptoms
What Are the Treatments Tested in This Trial?
Interventions
- Prolonged Exposure in Primary Care (PE-PC)
- Transauricular Vagus Nerve Stimulation (taVNS)
Trial Overview
The study compares a device that stimulates the vagus nerve through the ear (taVNS) plus talk therapy (PE-PC) to a sham (inactive) device plus the same therapy. Treatment lasts 4 weeks with follow-up assessments up to 4 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Transauricular nerve stimulation (tAN) provided for 2 hours per day for weeks. Frequency: 25 Hz on inner region (ABVN), 100Hz on outer region (ATN), Pulse width: 250 µs, Duty cycle: 5 minutes on, 10 second off. Stimulation is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.
Sham will use the same device and schedule with a brief individualized suprasensory stimulation followed by a ramp down over 2 minutes. Sham is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Citations
1.
researchgate.net
researchgate.net/publication/389885355_Vagus_Nerve_Stimulation_Therapy_for_Treatment-Resistant_PTSDVagus Nerve Stimulation Therapy for Treatment-Resistant ...
PTSD behavioral symptoms clinically improved and this improvement persisted 6 months after vagal nerve stimulation treatment
Transcutaneous auricular vagus nerve stimulation (taVNS)
TaVNS has exhibited promising efficacy for migraine in patients aged 27–29 years ( 41 ), effectively shortening headache duration and lowering seizure frequency ...
Pain Neuroscience Education and Vagus Nerve ...
This research points to a significant deficiency in pain perception, awareness, and control in individuals with RA.
Safety and preliminary efficacy of transcutaneous auricular ...
Compared to baseline, knee pain was reduced by 1.27 (95 % CI, −1.74, −0.80) immediately after and by 1.87 (−2.33, −1.40) 15 min after tVNS; CPM improved ...
The Clinical Science Behind AVNT™ Neuromodulation
Discover the clinical science behind Nurosym and Parasym's AVNT technology, including published research on stress, sleep, HRV, inflammation ...
tcVNS for PTSD · Recruiting Participants for Clinical Trial ...
Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain,
Treatment of chronic low back pain with transcutaneous ...
Clinical studies and our pilot study have also shown that tVNS can significantly reduce symptoms of chronic pain and common comorbidities of chronic pain, such ...
(PDF) Transcutaneous Auricular Vagus Nerve Stimulation
Conclusion Our findings suggest that taVNS may be a safer alternative to invasive vagal nerve stimulation for treatment-resistant mood disorders ...
9.
withpower.com
withpower.com/trial/vagal-nerve-stimulation-for-traumatic-brain-injury-and-ptsd-ecfadVagal Nerve Stimulation for Traumatic Brain Injury and PTSD
Research has shown that non-invasive Vagal Nerve Stimulation (nVNS) is generally well-tolerated, with few side effects. improved 22 out of 27 concussion- ...
PTSD patients show long-term benefits with vagus nerve ...
In a recent clinical study, patients with treatment-resistant post-traumatic stress disorder were symptom-free up to six months after completing ...
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