BridgeMD
New treatment option for Depression
Official title taVNS or TMS or Both for Depression
ClinicalTrials.gov ID: NCT05725239
What this study is testing
- What it's testing
- The purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.