Clinical trial NCT05725239: taVNS or TMS or Both for Depression
Official title: Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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). For participants who already have a cervical VNS device, the investigators will not change their treatment and will use this in place of the taVNS. The investigators think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.


Eligibility 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.

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale
timeFrame: Through study completion, an average of 8 weeks
measure: Change in Patient Health Questionnaire 9
timeFrame: Through study completion, an average of 8 weeks
Secondary outcomes:
measure: Number of adverse outcomes
timeFrame: One week following conclusion of the trial
measure: Number of adverse outcomes
timeFrame: One month following conclusion of the trial
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina Institute of Psychiatry
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Mark George, MD
role: PRINCIPAL_INVESTIGATOR
References: