Clinical trial NCT06026904: The Effects of taVNS on Motivation in MDD With Anhedonia
Official title: The Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Motivation in Major Depressive Disorder With Anhedonia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Keywords: taVNS
anhedonia
intervention
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will enroll two groups of patients with Major Depressive Disorder (MDD): one group will receive active transcutaneous auricular Vagus Nerve Stimulation (taVNS) treatment, while the other group will receive sham taVNS treatment (the same flow path, but targeting a different stimulation site).
Primary purpose: TREATMENT

Brief summary: Study of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) intervention to improve the reward motivation and response inhibition of major depression disorder and its brain network mechanism.

Detailed description: Anhedonia is the core symptom of MDD, which means they have deficits in processing rewards.MDD get lesser positive feelings than healthy controls from rewards as they could not use the reward outcome to update the value of a stimulus, which in consequence impedes their reward motivation or response inhibition and worsen their symptom. This study is dedicated to revealing how reward motivation or response inhibition ability could be intervened by taVNS intervention, which has been proven is highly relevant to reward motivation and response inhibition ability. Implementing a safer intervention of taVNS stimulation might help us to prove a better treatment for patients.

All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after taVNS stimulation treatment. Before and after the taVNS treatment, depression symptom of each participant was assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation Scale, the Positive Valence system scale and the Motivation and Pleasure Scale. The neuroimaging data are collected using event-related potentials during the effort reward task and stop signal task before and after the intervention. Patients were randomly allocated into an active group and a sham group. This study plans to enroll a minimum total sample size of 30 participants in active and sham group respectively according to the Power and Sample Size program. The decision to enroll a patient was always made prior to randomization. Each patient will be treated for 4 weeks with 25Hz taVNS. Each participant was interviewed in detail about the adverse event of the taVNS intervention during 10 days. Every participant should take part in the study voluntarily and sign an informed consent form before the study.

Eligibility criteria: Inclusion Criteria:

Meet the criteria of depression assessed by at least two psychiatrists according to the fifth version of Diagnostic and Statistical Manual of Mental Disorders.

The score of Hamilton Depression Rating Scale-17 is larger than 18 and the score of the Apathy Evaluation scale is lager than 37.

Patients were taking antidepressants--Selective Serotonin Reuptake Inhibitor(SSRIs) alone.

Age was between 18 to 60 year old. The education duration was at least 6 years.

The vision or corrected vision was normal.

Right handedness.

No treatment of rTMS, transcranial direct current stimulation, or electroconvulsive therapy before.

Exclusion Criteria:

History of significant head trauma or neurological disorders.

Alcohol or drug abuse.

Focal brain lesions.

History of seizure.

First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.

Significant unstable medical condition.

Recent aggression or other forms of behavioral dyscontrol.

Left-handedness.

Pregnancy.

Current alcohol or drug abuse

Inability to provide informed consent.

Patients with contraindications or factors affecting imaging quality, such as pacemakers, cochlear implants, or hearts Cerebrovascular metal stent, and metal denture.

Primary outcomes:
measure: Change from baseline in Hamilton Depression Scale
timeFrame: baseline;10days after treatment; 1month and 3 month post-treatment
measure: Change from baseline in Apathy Evaluation Scale
timeFrame: baseline;10days after treatment; 1month and 3 month post-treatment
Secondary outcomes:
measure: The change from baseline in behavioral results of effort reward task
timeFrame: baseline;4 weeks post-treatment
measure: The change from baseline in event-related brain potentials during the effort reward task
timeFrame: baseline;4 weeks post-treatment
measure: The change from baseline in behavioral results of stop signal task
timeFrame: baseline;4 weeks post-treatment
measure: The change from baseline in event-related brain potentials during the stop signal task
timeFrame: baseline;4 weeks post-treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Kai Wang, MD
role: STUDY_CHAIR
affiliation: Anhui Medical University
name: Fengqiong Yu, MD
role: STUDY_DIRECTOR
affiliation: Anhui Medical University
name: Rong Ye, Phd
role: STUDY_DIRECTOR
References: