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NCT Number: NCT05725239

taVNS or TMS or Both for Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, 29412, United States

Location status: Recruiting

Location contact

Elisabeth Collins

CONTACT

[email protected]

Mark George

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vagus nerve stimulation

Device

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.

Transcranial Magnetic Stimulation

Device

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 outcomes

  1. Change in Hamilton Depression Rating Scale

    Time frame: Through study completion, an average of 8 weeks

    The Hamilton Depression Rating Scale (HDRS) is a commonly used clinician-administered depression rating scale to assess severity of depressive symptoms. The HDRS has a possible score range of 0-52. The higher the HDRS score, the more severe the depressive symptoms are in that patient.

  2. Change in Patient Health Questionnaire 9

    Time frame: Through study completion, an average of 8 weeks

    The Patient Health Questionnaire 9 (PHQ-9) is a brief self-administered questionnaire to assess depressive symptoms. The PHQ-9 has a possible score range of 0-27. The higher the PHQ-9 score, the more severe the depressive symptoms are in that patient.

Secondary outcomes

  1. Number of adverse outcomes

    Time frame: One week following conclusion of the trial

    Participants will be called at the 1 week and 1 month timepoints following their completion of the trial to inquire about any adverse outcomes they have experienced, if any, since the conclusion of the trial as a means of measuring feasibility of the treatment.

  2. Number of adverse outcomes

    Time frame: One month following conclusion of the trial

    Participants will be called at the 1 week and 1 month timepoints following their completion of the trial to inquire about any adverse outcomes they have experienced, if any, since the conclusion of the trial as a means of measuring feasibility of the treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark George

CONTACT

[email protected]

843-876-5142

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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