The Effects of taVNS on Motivation in MDD With Anhedonia

NCT06026904 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: Y&C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

taVNS; anhedonia; intervention

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Hamilton Depression Scale

  The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment. Score reference value: \<7 points, no depression;7 to 17points, mild depression;18to 24 points, moderate depression; \> 24 points, severe depression. If remission rate reaches 50%, the treatment will be considered effective.

  baseline;10days after treatment; 1month and 3 month post-treatment

• Change from baseline in Apathy Evaluation Scale

  The participants' reward motivation assessed by the Apathy Evaluation Scale change from baseline after the treatment. Score reference value: \<37 points, no apathy; ≥37points, apathy. If remission rate reaches 25%, the treatment will be considered effective.

  baseline;10days after treatment; 1month and 3 month post-treatment

Secondary Outcomes (4)

• The change from baseline in behavioral results of effort reward task

  baseline;4 weeks post-treatment

• The change from baseline in event-related brain potentials during the effort reward task

  baseline;4 weeks post-treatment

• The change from baseline in behavioral results of stop signal task

  baseline;4 weeks post-treatment

• The change from baseline in event-related brain potentials during the stop signal task

  baseline;4 weeks post-treatment

Study Arms (2)

Active Comparator: Real Stimulation

ACTIVE COMPARATOR

The active Stimulation of taVNS lasted 30 mins. The stimulation protocol is preset to a biphasic impulse frequency of 25 Hz with a stimulation duration of 30 s, followed by a 30 s off phase. Behavior and ERPs datasets should be acquired before the first taVNS session and after the last taVNS session.The electrical current is transmitted by a titanium electrode placed at the cymba conchae.

Device: transcutaneous auricular vagus nerve stimulation

Sham Comparator: Sham Stimulation

SHAM COMPARATOR

The active Stimulation of taVNS lasted 30 mins. The stimulation protocol is preset to a biphasic impulse frequency of 25 Hz with a stimulation duration of 30 s, followed by a 30 s off phase. Behavior and ERPs datasets should be acquired before the first taVNS session and after the last taVNS session.The electrical current is transmitted by a titanium electrode placed at the earlobe of the midpoint of the outer ear margin.

Device: transcutaneous auricular vagus nerve stimulation

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

taVNS was developed as a non-invasive variant of VNS where the vagus nerve is stimulated through the skin of the auricle, which has become a promising avenue for research and, potentially, treatment of various disorders. Commonly, taVNS is applied via the ear targeting the auricular branch of the vagus nerve, where the stimulation elicits far-field potentials. In line with preclinical studies, acute taVNS enhances invigoration of effort and response inhibition capability.

Active Comparator: Real Stimulation; Sham Comparator: Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Depression; Anhedonia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kai Wang, MD

  Anhui Medical University

  STUDY CHAIR

• Fengqiong Yu, MD

  Anhui Medical University

  STUDY DIRECTOR

• Rong Ye, Phd

  Anhui Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: March 30, 2023
• Primary Completion: December 31, 2024
• Study Completion: September 30, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CN (1)