taVNS or TMS or Both for Depression

NCT ID: NCT05725239

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2026-07-01

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vagus Nerve Stimulation (VNS) only

Group Type: EXPERIMENTAL

Vagus Nerve Stimulation

Intervention Type: 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 (TMS) only

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: 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.

Synchronized VNS and TMS

Group Type: EXPERIMENTAL

Vagus Nerve Stimulation

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Mark George

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark George, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark George

Role: CONTACT

georgem@musc.edu

843-876-5142

Facility Contacts

Mark George

Role: primary

georgem@musc.edu

Elisabeth Collins

Role: backup

collieli@musc.edu

Other Identifiers

00125468

Identifier Type: -

Identifier Source: org_study_id