taVNS or TMS or Both for Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725239
• Other study ID #: 00125468
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2024
• Source: Medical University of South Carolina
• Contact: Mark George
• Phone: 843-876-5142
• Email: georgem[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina Institute of Psychiatry	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Rating Scale	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.	Through study completion, an average of 8 weeks
Primary	Change in Patient Health Questionnaire 9	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.	Through study completion, an average of 8 weeks
Secondary	Number of adverse outcomes	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.	One week following conclusion of the trial
Secondary	Number of adverse outcomes	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.	One month following conclusion of the trial