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Behavioural Intervention

taVNS + TMS for Depression

N/A
Recruiting
Led By Noah Vieira
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-75 years old
English speaking and can read and write
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month following conclusion of the trial
Awards & highlights

Study Summary

This trial tests combining two treatments—nerve stimulation & magnetic stimulation—to treat depression better than either one alone. In-person at MUSC in Charleston, SC.

Who is the study for?
This trial is for adults aged 18-75 with severe depression, who haven't improved with talk therapy and have tried at least two antidepressants without success. It's also open to those already using cervical VNS. Participants must be able to consent, speak English, and not be pregnant or at high risk of suicide.Check my eligibility
What is being tested?
The study tests a combined depression treatment involving ear nerve stimulation (taVNS) and brain magnetic stimulation (TMS), separately or together. Over six sessions at the MUSC campus in Charleston, treatments are randomized across different days to assess which combination might best alleviate symptoms.See study design
What are the potential side effects?
Potential side effects may include discomfort from ear stimulation, headache or scalp sensations from TMS, temporary hearing changes due to taVNS, and mild dizziness or nausea. More serious risks could involve seizures from TMS but are considered rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I can speak, read, and write in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month following conclusion of the trial
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month following conclusion of the trial for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hamilton Depression Rating Scale
Change in Patient Health Questionnaire 9
Secondary outcome measures
Number of adverse outcomes

Trial Design

3Treatment groups
Experimental Treatment
Group I: Vagus Nerve Stimulation (VNS) onlyExperimental Treatment1 Intervention
Group II: Transcranial Magnetic Stimulation (TMS) onlyExperimental Treatment1 Intervention
Group III: Synchronized VNS and TMSExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vagus Nerve Stimulation
2019
N/A
~50
Transcranial Magnetic Stimulation
2011
Completed Phase 4
~710

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
930 Previous Clinical Trials
7,393,787 Total Patients Enrolled
40 Trials studying Depression
6,929 Patients Enrolled for Depression
Mark George, MDStudy ChairMedical University of South Carolina
2 Previous Clinical Trials
1,019 Total Patients Enrolled
1 Trials studying Depression
795 Patients Enrolled for Depression
Noah VieiraPrincipal InvestigatorMedical University of South Carolina

Media Library

taVNS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05725239 — N/A
Depression Research Study Groups: Vagus Nerve Stimulation (VNS) only, Transcranial Magnetic Stimulation (TMS) only, Synchronized VNS and TMS
Depression Clinical Trial 2023: taVNS Highlights & Side Effects. Trial Name: NCT05725239 — N/A
taVNS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05725239 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are volunteering for this experiment?

"Affirmative. On clinicaltrials.gov, the trial is listed as actively recruiting with an original posting date of March 14th 2023 and a most recent edit on April 30th 2023. The study needs 24 volunteers from 1 site to reach its quota of participants."

Answered by AI

Are there currently any openings available for participants of this research?

"As per the details provided on clinicaltrials.gov, this research project is actively searching for volunteers to partake in their experiment. It was introduced on March 14th 2023 and edited most recently at the end of April 2023."

Answered by AI

Is the age requirement for participation in this trial eighteen years or older?

"This trial is only open to those aged 18-75; if a patient falls outside of this age range, there are 206 trials for younger patients and 991 clinical studies for seniors."

Answered by AI

Who is eligible to enroll in this research?

"This trial is seeking 24 participants with depression, aged between 18 and 75. The ideal candidate must fulfill the following criteria: be within this age range, have either undergone cervical VNS or tried two failed antidepressant medications in their current episode, provide informed consent; demonstrate English literacy and comprehension of written materials; score a 17-item Hamilton Depression Rating Scale (HAM-D) result of at least 20 points; show no response to talking therapy."

Answered by AI
~3 spots leftby Jun 2024