taVNS or TMS or Both for Depression
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Vagus Nerve Stimulation
DeviceAll 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
DeviceParticipants 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.
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Vagus Nerve Stimulation (VNS) onlyExperimental treatment 1 intervention
Group B: Transcranial Magnetic Stimulation (TMS) onlyExperimental treatment 1 intervention
Group C: Synchronized VNS and TMSExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 8 weeks2
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.
Time frame
Through study completion, an average of 8 weeksSecondary outcomes
1
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.
Time frame
One week following conclusion of the trial2
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.
Time frame
One month following conclusion of the trialSponsors and contacts
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Source ClinicalTrials.gov