Combining ear nerve stimulation and brain magnetic stimulation for depression treatment
Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)
This study is testing if combining ear nerve stimulation with brain magnetic stimulation can help people with depression who haven’t found relief from regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT05725239 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate a combined treatment approach for depression by using transcutaneous auricular vagus nerve stimulation (taVNS) alongside transcranial magnetic stimulation (TMS). Participants will undergo a screening session followed by six treatment days, where they will receive either taVNS, TMS, or both in a randomized order. The study is conducted in-person at the Institute of Psychiatry in Charleston, South Carolina, and targets individuals who have not responded to traditional antidepressant medications. The goal is to determine if this combined method can more effectively alleviate depressive symptoms compared to each treatment alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who are experiencing depression and have either undergone cervical VNS or have tried and failed two antidepressant medications.
Not a fit: Patients with preexisting neurological disorders, significant cognitive impairments, or current suicidal intent may not benefit from this study.
Why it matters
Potential benefit: If successful, this combined treatment could provide a more effective option for patients suffering from depression who have not responded to standard therapies.
How similar studies have performed: While the combination of taVNS and TMS is a novel approach, similar studies exploring each treatment individually have shown promise in alleviating depressive symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-75 years old * Undergoing cervical VNS or have tried and failed two antidepressant medications in the current episode * Able to provide informed consent * English speaking and can read and write * 17-item Hamilton Depression Rating Scale (HAM-D) score ≥20 * Not responding to talking therapy. Exclusion Criteria: * Preexisting neurological disorders, or dementia * History of major head trauma * Life expectancy \<1 year * Any type of cognitive impairment that would require approval/signature of a legal guardian/representative for participation * A score of \>2 on question 3 of the Hamilton Depression Rating pertaining to suicidality * Current active suicidal intent or plan, prior attempt within the last 6 months, or who in the judgment of the investigator would be at elevated risk for suicide will be excluded * Patients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina Institute of Psychiatry — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Mark George, MD — Medical University of South Carolina
- Study coordinator: Mark George
- Email: georgem@musc.edu
- Phone: 843-876-5142
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.