Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389175
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-09
First Post:
2024-04-24
Brief Title:
Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression
Sponsor:
University of Bonn
Organization:
University of Bonn
Study Overview
Official Title:
Keeping Mind and Body in Sync Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overarching goal of the project is to determine whether differences in stomach-brain coupling contribute to key symptoms of major depressive disorder MDD and whether transcutaneous non-invasive vagus nerve stimulation tVNS may serve as a non-invasive intervention to improve aberrant interoceptive signaling in participants suffering from MDD
Detailed Description:
It is planned to conduct a randomized cross-over study including two neuroimaging sessions to assess the effect of acute tVNS vs sham on stomach-brain coupling using concurrent fMRI and EGG Furthermore to evaluate potential medium-term effects of repeated applications of tVNS vs sham changes across two weeks in gastric myoelectric frequency and interoceptionsomatic sensations as well as metabolic and mood states will be evaluated using a combination of lab-based with ecological momentary assessments EMA
Consequently three major hypotheses will be tested
Hypothesis 1 Participants suffering from MDD show altered stomach-brain coupling compared to matched healthy control participants inter-individual differences in interoceptive measuressomatic sensations correlate with stomach-brain coupling
Hypothesis 2 tVNS enhances stomach-brain coupling in a vagal afferent network
Hypothesis 3 In participants suffering from MDD tVNS influences interoceptionsomatic sensations and normalizes gastric myoelectric frequency over an extended stimulation period
In addition to these main outcomes tNVS effects on value-based decision-making will be investigated In detail participants will be invited to two neuroimaging sessions T1 and T2 including tVNS or a sham stimulation At the beginning of each of these sessions blood will be drawn to determine concentrations of circulating hormones Afterwards participants will undergo MRI and complete the following tasks 1 Watching an Inscape movie specifically designed to improve imaging at rest After a 10-minutes baseline scan tVNSsham stimulation will start and the Inscape scan is repeated 2 Food bidding task to assess neural food cue reactivity as well as bidding behavior and its neural correlates when participants are asked to bid for accessing the presented food 3 Foraging task to assess value-based decision-making and its neural correlates with the goal to maximize points in different environments poor and rich environment After completing the food bidding and foraging task the Inscape movie is presented once more to assess tVNS effects after a prolonged stimulation Throughout all MRI tasks stomach activity will be assessed by an EGG Both neuroimaging sessions end with an additional blood draw
Following the neuroimaging sessions participants will be invited to two extended stimulation periods tVNS vs sham each lasting approximately two weeks At the beginning of the extended stimulation periods participants will be invited to the lab and blood will be drawn T3 Gastric myoelectric frequency using EGG and value-based decision-making will be assessed at baseline and during stimulation tVNS or sham After completing the session participants are given a tVNS device and are asked to stimulate their vagus nerve for 15h at least on four days during the following two weeks During this time period participants complete further tasks on value-based decision-making and questionnaires using ecological momentary assessments In detail four tasks will cover different aspects of value-based decision making 1 Effort allocation task motivation to work for rewards completed at T3-T6 2 temporal discounting completed during the whole extended stimulation period 3 social discounting completed during the whole extended stimulation period and 4 Influenca gamified reinforcement learning completed during the whole extended stimulation period
After two weeks participants will again come to the lab and EGG recordings and value-based decision-making tasks will be repeated T4 Likewise another blood sample will be collected The extended stimulation period will then be repeated in the same way for the other stimulation type tVNS or sham including both sessions in the lab T5 and T6 The order of tVNS and sham stimulation is randomized for both neuroimaging sessions as well as the extended stimulation period
Consequently three major hypotheses will be tested
Hypothesis 1 Participants suffering from MDD show altered stomach-brain coupling compared to matched healthy control participants inter-individual differences in interoceptive measuressomatic sensations correlate with stomach-brain coupling
Hypothesis 2 tVNS enhances stomach-brain coupling in a vagal afferent network
Hypothesis 3 In participants suffering from MDD tVNS influences interoceptionsomatic sensations and normalizes gastric myoelectric frequency over an extended stimulation period
In addition to these main outcomes tNVS effects on value-based decision-making will be investigated In detail participants will be invited to two neuroimaging sessions T1 and T2 including tVNS or a sham stimulation At the beginning of each of these sessions blood will be drawn to determine concentrations of circulating hormones Afterwards participants will undergo MRI and complete the following tasks 1 Watching an Inscape movie specifically designed to improve imaging at rest After a 10-minutes baseline scan tVNSsham stimulation will start and the Inscape scan is repeated 2 Food bidding task to assess neural food cue reactivity as well as bidding behavior and its neural correlates when participants are asked to bid for accessing the presented food 3 Foraging task to assess value-based decision-making and its neural correlates with the goal to maximize points in different environments poor and rich environment After completing the food bidding and foraging task the Inscape movie is presented once more to assess tVNS effects after a prolonged stimulation Throughout all MRI tasks stomach activity will be assessed by an EGG Both neuroimaging sessions end with an additional blood draw
Following the neuroimaging sessions participants will be invited to two extended stimulation periods tVNS vs sham each lasting approximately two weeks At the beginning of the extended stimulation periods participants will be invited to the lab and blood will be drawn T3 Gastric myoelectric frequency using EGG and value-based decision-making will be assessed at baseline and during stimulation tVNS or sham After completing the session participants are given a tVNS device and are asked to stimulate their vagus nerve for 15h at least on four days during the following two weeks During this time period participants complete further tasks on value-based decision-making and questionnaires using ecological momentary assessments In detail four tasks will cover different aspects of value-based decision making 1 Effort allocation task motivation to work for rewards completed at T3-T6 2 temporal discounting completed during the whole extended stimulation period 3 social discounting completed during the whole extended stimulation period and 4 Influenca gamified reinforcement learning completed during the whole extended stimulation period
After two weeks participants will again come to the lab and EGG recordings and value-based decision-making tasks will be repeated T4 Likewise another blood sample will be collected The extended stimulation period will then be repeated in the same way for the other stimulation type tVNS or sham including both sessions in the lab T5 and T6 The order of tVNS and sham stimulation is randomized for both neuroimaging sessions as well as the extended stimulation period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KR 455510-1 | OTHER_GRANT | Deutsche Forschungsgemeinschaft DFG | None |