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tVNS Effects on Motivation in Depression

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
transcutaneous vagus nerve stimulation
sham stimulation
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring vagus nerve stimulation, food reward, anhedonia, vigor, reward learning, mood

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 30 kg/m^2 > BMI > 18.5 kg/m^2

Exclusion Criteria:

lifetime

  • brain injury
  • coronary heart disease and occurred apoplexy
  • schizophrenia
  • bipolar disorder
  • implants (e.g., cochlea implant)
  • asthma

    12 month

  • severe substance use disorders (DSM-V), except tobacco
  • obessive compulsive disorder
  • somatic symptom disorder
  • eating disorder

Sites / Locations

  • Department of Psychiatry & Psychotherapy, University of Tübingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Non-depressed control participants: sham first, active taVNS second

Patients with major depressive disorders: sham first, active taVNS second

Patients with major depressive disorders: active taVNS first, sham second

Non-depressed control participants: active taVNS first, sham second

Arm Description

Non-depressed control participants receive sham stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the earlobe (sham) for 1.5 h). In a second identical session, they receive active stimulation with the same parameters (at the cymba conchae).

participants with depression receive sham stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the earlobe (sham) for 1.5 h). In a second identical session, they receive active stimulation with the same parameters (at the cymba conchae).

participants with depression receive active stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the cymba conchae (active) for 1.5 h). In a second identical session, they receive sham stimulation with the same parameters (at the earlobe).

Non-depressed control participants receive active stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the cymba conchae (active) for 1.5 h). In a second identical session, they receive sham stimulation with the same parameters (at the earlobe).

Outcomes

Primary Outcome Measures

Food reward ratings
Operationalized via visual analogue scale ratings of liking [-100 - 100] and wanting [0-100] in a food cue reactivity task
Motivation to work for rewards: frequency of button presses to gain food an monetary rewards
Operationalized via the relative frequency of button presses on an Xbox controller in an effort allocation task during either the first seconds of each trial (invigoration) or each complete trial (maintenance)
Reward learning: correct choices
Operationalized via number of correct value-based choices in a valenced go/no-go learning task
Positive and negative mood
Operationalized via visual analogue ratings (0-100) of positive and negative affect schedule mood items

Secondary Outcome Measures

Full Information

First Posted
October 18, 2021
Last Updated
November 24, 2021
Sponsor
University Hospital Tuebingen
Collaborators
Universität Tübingen
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1. Study Identification

Unique Protocol Identification Number
NCT05120336
Brief Title
tVNS Effects on Motivation in Depression
Official Title
The Effects of Transcutaneous Vagus Nerve Stimulation on Motivation in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
January 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
Collaborators
Universität Tübingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Attaining goals or rewards commonly entails response costs. In light of cost and benefits, how do participants decide what effort should be put in to give it a shot? Figuratively, you may "go with your gut", but the literal contribution of the gut-brain axis in allocating effort is poorly understood to date. Here, the investigators propose to investigate non-invasive transcutaneous vagal nerve stimulation (tVNS) as a potential modulator of energy metabolism and response vigor. Since the neural mechanisms causing the diverse cognitive and behavioral effects of the stimulation remain largely elusive, the investigators will use computational modeling of instrumental behavior and determine the primary metabolic effects of the stimulation. The investigators hypothesize that tVNS will lead to activation of afferent targets in the brain. In turn, the elicited brain activation is expected to mediate the cognitive effects of the stimulation. This may affect both sides of the utility equation because anti-depressive effects may correspond to boosting the benefit of effort whereas anti-nociceptive effects may reduce perceived costs of effort. Collectively, dissecting the cognitive effects of non-invasive tVNS in healthy individuals may facilitate the more widespread use as a treatment in mental disorders that are characterized by metabolic alterations such as depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
vagus nerve stimulation, food reward, anhedonia, vigor, reward learning, mood

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-depressed control participants: sham first, active taVNS second
Arm Type
Experimental
Arm Description
Non-depressed control participants receive sham stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the earlobe (sham) for 1.5 h). In a second identical session, they receive active stimulation with the same parameters (at the cymba conchae).
Arm Title
Patients with major depressive disorders: sham first, active taVNS second
Arm Type
Experimental
Arm Description
participants with depression receive sham stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the earlobe (sham) for 1.5 h). In a second identical session, they receive active stimulation with the same parameters (at the cymba conchae).
Arm Title
Patients with major depressive disorders: active taVNS first, sham second
Arm Type
Experimental
Arm Description
participants with depression receive active stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the cymba conchae (active) for 1.5 h). In a second identical session, they receive sham stimulation with the same parameters (at the earlobe).
Arm Title
Non-depressed control participants: active taVNS first, sham second
Arm Type
Experimental
Arm Description
Non-depressed control participants receive active stimulation in the first session (biphasic stimulation with a frequenyc of 25 Hz, 30s OFF/30s ON at the cymba conchae (active) for 1.5 h). In a second identical session, they receive sham stimulation with the same parameters (at the earlobe).
Intervention Type
Device
Intervention Name(s)
transcutaneous vagus nerve stimulation
Other Intervention Name(s)
transcutaneous auricular vagus nerve stimulation
Intervention Description
Non-invasive brain stimulation technique that is used to stimulate vagal afferent projections to the nucleus of the solitary tract. Invasive VNS has been approved for the treatment of treatment-resistant depression.
Intervention Type
Device
Intervention Name(s)
sham stimulation
Other Intervention Name(s)
transcutaneous stimulation of the earlobe
Intervention Description
Sham procedure for active transcutaneous vagus nerve stimulation
Primary Outcome Measure Information:
Title
Food reward ratings
Description
Operationalized via visual analogue scale ratings of liking [-100 - 100] and wanting [0-100] in a food cue reactivity task
Time Frame
during stimulation (compared to sham)
Title
Motivation to work for rewards: frequency of button presses to gain food an monetary rewards
Description
Operationalized via the relative frequency of button presses on an Xbox controller in an effort allocation task during either the first seconds of each trial (invigoration) or each complete trial (maintenance)
Time Frame
during stimulation (compared to sham)
Title
Reward learning: correct choices
Description
Operationalized via number of correct value-based choices in a valenced go/no-go learning task
Time Frame
during stimulation (compared to sham)
Title
Positive and negative mood
Description
Operationalized via visual analogue ratings (0-100) of positive and negative affect schedule mood items
Time Frame
Pre stimulation and 20 minutes post stimulation (compared to sham)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 30 kg/m^2 > BMI > 18.5 kg/m^2 Exclusion Criteria: lifetime brain injury coronary heart disease and occurred apoplexy schizophrenia bipolar disorder implants (e.g., cochlea implant) asthma 12 month severe substance use disorders (DSM-V), except tobacco obessive compulsive disorder somatic symptom disorder eating disorder
Facility Information:
Facility Name
Department of Psychiatry & Psychotherapy, University of Tübingen
City
Tübingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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tVNS Effects on Motivation in Depression

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