Major Depressive DisorderNCT05120336
tVNS Effects on Motivation in Depression
A study testing transcutaneous vagus nerve stimulation in people with Major Depressive Disorder, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- transcutaneous vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteGermany
- Study dates
- 11 Dec 2019to 29 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30 kg/m^2 > BMI > 18.5 kg/m^2
Who cannot join
- lifetime
- brain injury
- coronary heart disease and occurred apoplexy
- schizophrenia
- bipolar disorder
- implants (e.g., cochlea implant)
Show all 12Show fewer
- asthma
- 12 month
- severe substance use disorders (DSM-V), except tobacco
- obessive compulsive disorder
- somatic symptom disorder
- eating disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry & Psychotherapy, University of Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: The Effects of Transcutaneous Vagus Nerve Stimulation on Motivation in Major Depressive Disorder
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.
- Conditions
- Major Depressive Disorder
- Being tested
- transcutaneous vagus nerve stimulation, sham stimulation
- Keywords
- vagus nerve stimulation, food reward, anhedonia, vigor, reward learning, mood
- Medical subject headings
- Depressive Disorder, Major, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagus nerve stimulationDevice
Also called transcutaneous auricular vagus nerve stimulation
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.
sham stimulationDevice
Also called transcutaneous stimulation of the earlobe
Sham procedure for active transcutaneous vagus nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Non-depressed control participants: sham first, active taVNS second | Experimental | 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). Receives: Device: transcutaneous vagus nerve stimulation; Device: sham stimulation |
| Patients with major depressive disorders: sham first, active taVNS second | Experimental | 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). Receives: Device: transcutaneous vagus nerve stimulation; Device: sham stimulation |
| Patients with major depressive disorders: active taVNS first, sham second | Experimental | 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). Receives: Device: transcutaneous vagus nerve stimulation; Device: sham stimulation |
| Non-depressed control participants: active taVNS first, sham second | Experimental | 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). Receives: Device: transcutaneous vagus nerve stimulation; Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food reward ratings
Operationalized via visual analogue scale ratings of liking [-100 - 100] and wanting [0-100] in a food cue reactivity task
Measured: during stimulation (compared to sham)
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)
Measured: during stimulation (compared to sham)
Reward learning: correct choices
Operationalized via number of correct value-based choices in a valenced go/no-go learning task
Measured: during stimulation (compared to sham)
Positive and negative mood
Operationalized via visual analogue ratings (0-100) of positive and negative affect schedule mood items
Measured: Pre stimulation and 20 minutes post stimulation (compared to sham)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start11 Dec 2019
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120336
- Sponsor's protocol ID
- NBK_TUE004
- Status last verified
- Oct 2021
- First submitted
- 18 Oct 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcutaneous Vagus Nerve Stimulation on Motivation in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05120336
- Acronym / sponsor ID
- NBK_TUE004
- Conditions
- Major Depressive Disorder
- Keywords
- vagus nerve stimulation, food reward, anhedonia, vigor, reward learning, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Universität Tübingen
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-depressed control participants: sham first, active taVNS second | Experimental | Device: transcutaneous vagus nerve stimulation, Device: sham stimulationNon-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). |
| Patients with major depressive disorders: sham first, active taVNS second | Experimental | Device: transcutaneous vagus nerve stimulation, Device: sham stimulationparticipants 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). |
| Patients with major depressive disorders: active taVNS first, sham second | Experimental | Device: transcutaneous vagus nerve stimulation, Device: sham stimulationparticipants 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: active taVNS first, sham second | Experimental | Device: transcutaneous vagus nerve stimulation, Device: sham stimulationNon-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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 30 kg/m^2 > BMI > 18.5 kg/m^2
Key exclusion criteria (12 listed)
- lifetime
- brain injury
- coronary heart disease and occurred apoplexy
- schizophrenia
- bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous vagus nerve stimulationAlso: transcutaneous auricular vagus nerve stimulationNon-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. | Device | Non-depressed control participants: active taVNS first, sham second, Non-depressed control participants: sham first, active taVNS second, Patients with major depressive disorders: active taVNS first, sham second, Patients with major depressive disorders: sham first, active taVNS second |
| sham stimulationAlso: transcutaneous stimulation of the earlobeSham procedure for active transcutaneous vagus nerve stimulation | Device | Non-depressed control participants: active taVNS first, sham second, Non-depressed control participants: sham first, active taVNS second, Patients with major depressive disorders: active taVNS first, sham second, Patients with major depressive disorders: sham first, active taVNS second |
Primary outcome
Food reward ratings
Time frame: during stimulation (compared to sham)
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
Time frame: during stimulation (compared to sham)
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
Time frame: during stimulation (compared to sham)
Operationalized via number of correct value-based choices in a valenced go/no-go learning task
Positive and negative mood
Time frame: Pre stimulation and 20 minutes post stimulation (compared to sham)
Operationalized via visual analogue ratings (0-100) of positive and negative affect schedule mood items
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous vagus nerve stimulation in people with Major Depressive Disorder, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food reward ratings (time frame: during stimulation (compared to sham)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.