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taVNS or TMS or Both for Depression

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vagus Nerve Stimulation
Transcranial Magnetic Stimulation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina Institute of PsychiatryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Vagus Nerve Stimulation (VNS) only

Transcranial Magnetic Stimulation (TMS) only

Synchronized VNS and TMS

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 18, 2023
Last Updated
April 30, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05725239
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vagus Nerve Stimulation (VNS) only
Arm Type
Experimental
Arm Title
Transcranial Magnetic Stimulation (TMS) only
Arm Type
Experimental
Arm Title
Synchronized VNS and TMS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vagus Nerve Stimulation
Intervention Description
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
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
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 Measure Information:
Title
Change in Hamilton Depression Rating Scale
Description
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.
Time Frame
Through study completion, an average of 8 weeks
Title
Change in Patient Health Questionnaire 9
Description
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.
Time Frame
Through study completion, an average of 8 weeks
Secondary Outcome Measure Information:
Title
Number of adverse outcomes
Description
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.
Time Frame
One week following conclusion of the trial
Title
Number of adverse outcomes
Description
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.
Time Frame
One month following conclusion of the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noah Vieira
Phone
843-876-5141
Email
vieira@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Vieira
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark George, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of South Carolina Institute of Psychiatry
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Vieira
Email
vieira@musc.edu
First Name & Middle Initial & Last Name & Degree
Elisabeth Collins
Email
collieli@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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taVNS or TMS or Both for Depression

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