taVNS or TMS or Both for Depression

Official title

Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)

Overview

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.

Interventions

• Device Vagus Nerve Stimulation
  All taVNS sessions will use the following parameters: 25Hz, 500us pulse width, on for 7 seconds, off for 12 seconds.The length of VNS treatment sessions will be identical to TMS treatment sessions and will have the same 30 minute break between each treatment session. These treatments (active or sham) will be administered to participants each treatment day, for a total of 6 different treatment days, but only 4 are active.
• Device Transcranial Magnetic Stimulation
  Participants will receive 20 trains of 30 pulses each for a total of 600 pulses per session. We will repeat this for 6 sessions each day, with at least 30 minutes between each session. These treatments (active or sham) will be administered to participants each treatment day, for a total of 6 different treatment days, but only 4 are active, so participants will get 24 TMS sessions over the course.

Primary outcome measures

• Change in Hamilton Depression Rating Scale [Time frame: Through study completion, an average of 8 weeks]
• Change in Patient Health Questionnaire 9 [Time frame: Through study completion, an average of 8 weeks]

Secondary outcome measures (2)

• Number of adverse outcomes [Time frame: One week following conclusion of the trial]
• Number of adverse outcomes [Time frame: One month following conclusion of the trial]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Medical University of South Carolina Institute of Psychiatry — Charleston

Identifiers

NCT: NCT05725239 · 00125468

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗