The Brain-heart-gut Connection (BHG-CONNECT): Targeting the Frontal-vagal Pathway to Personalize Noninvasive Brain Stimulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Major Depressive Disorder (MDD) often co-occurs with cardiovascular and gastrointestinal symptoms, highlighting the importance of the brain-heart-gut connection in developing comprehensive treatments. Previous research suggests that key hubs in the depression network, such as the dorsolateral prefrontal cortex (DLPFC) and the subgenual anterior cingulate cortex (sgACC), overlap with structures that are involved in autonomic control, particularly the vagus nerve. Repetitive transcranial magnetic stimulation (rTMS) to the left DLPFC is an established treatment for MDD; however, antidepressant efficacy varies greatly across individuals, and optimal DLPFC targeting remains a significant challenge. Personalized rTMS based on DLPFC-sgACC connectivity improves outcomes but is limited by practical and financial constraints. Recently, rTMS-induced heart-brain coupling (HBC) has emerged as a promising method to utilize heart rate responses to guide treatment. The primary goal of this project is to personalize HBC to improve DLPFC-based targeting for the treatment of MDD while also probing additional readouts of the frontal-vagal system. In Study Arm 1, we will implement an innovative frontal mapping technique to identify the personalized Grid-Spot that elicits the strongest HBC in healthy participants. In subsequent visits, we will compare heart rate responses during the 10Hz Dash protocol between the Grid-Spot, conventional DLPFC targeting using Beam-F3 and an active control region (Cz). Additionally, we will integrate various autonomic nervous system (ANS) measures, including gut motility, pupil dilation and electrodermal activity (EDA), to explore the brain-heart-gut axis and assess their utility in improving target engagement. Furthermore, we will extend our methodology to the personalized application of high-definition transcranial direct current stimulation (HD-tDCS). Specifically, we will explore the effects of anodal versus sham HD-tDCS over the HBC-guided Grid-Spot on ANS readouts and compare these outcomes to those observed with rTMS. In Study Arm 2, we will repeat experimental rTMS visits from Study Arm 1 with participants exhibiting elevated symptom scores in depression, autonomic dysfunction and functional dyspepsia. In Study Arm 2 we will also validate our optimal Grid-Spot identification through neuroimaging of DLPFC-sgACC connectivity. This project will deepen our understanding of the brain-heart-gut connection and contribute to more accessible, personalized brain stimulation treatments for MDD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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⁃ In study arm 1, all participants are healthy between 18 and 65 years of age, and able to give written informed consent.

⁃ In study arm 2, all participants must be between 18 and 65 years of age and additionally fulfill the following criteria:

• Elevated autonomic symptom score (\> 20) on the Composite Autonomic Symptom Score

• Depressive symptoms indicated by an elevated score (\>5) in the Patient Health Care Questionnaire (PHQ-9?) or elevated scores (\>9) in the Depression Anxiety and Stress Scale (DASS).

• Elevated Score on Selected questions of the Subchapter symptoms in the Stomach or Intestines of the Rome IV Diagnostic Questionnaire for Adult Functional Gastrointestinal Disorders (Drossman, D. A. (Ed.). (2016). Rome IV: Functional Gastrointestinal Disorders - Disorders of Gut-Brain Interaction (4th ed.). Rome Foundation)

⁃ For both arms, the following criteria must be fulfilled:

• Normal or corrected-to-normal vision and hearing.

• Willingness to participate and signed informed consent

• No Medication with cognitive side effects (e.g. psychoactive medications or sleeping pills) or medication affecting gastric motility

• No ectopic heartbeat

• No history of epilepsy or seizure

• No metal implants or devices (e.g. cardiac pacemakers)

• No substance abuse or recent drug consumption

• No pregnancy

• No history of brain- heart- or gastrointestinal surgery

• No skin conditions

• BMI \<30

Locations
Other Locations
Switzerland
University Hospital of Old Age Psychiatry and Psychotherapy Bern
RECRUITING
Bern
Contact Information
Primary
Jessica Jacobs, Msc
Jessica.jacobs@unibe.ch
+41586306880
Backup
Anna-Katharine Brem, PD Dr.
katy.brem@gmail.com
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 98
Treatments
Other: Frontal Mapping
To identify the individual TMS stimulation spot and intensity, the Heart-Brain Coupling protocols described by Dijkstra and colleagues (2023) are applied over 8 different spots. To identify the individual stimulation intensity, trains of 10 Hz for 5 seconds with an inter-train interval of 11 seconds are applied (Dash protocol). The subjects are stimulated with 15 different intensities, raising in 2% machine output steps. The starting intensity is set as 28% below the motor threshold (MT), leading to the highest intensity level of 120% MT at step 15. The intensity causing the HR to decelerate the most will be taken as the individual stimulation intensity for subsequent sessions.
Experimental: TMS - Grid-spot
Subjects receive active rTMS over the individual DLPFC spot. Both sessions follow the same protocol and procedures. The 10Hz Dash protocol is applied for about 18.75minutes with the individual intensity defined in the frontal mapping session (arm 1).
Active_comparator: TMS control (Cz)
Subjects receive active TMS over the central midline. Both sessions follow the same protocol and procedures. The rTMS 10 Hz Dash protocol is applied for about 18.75 minutes with the individual intensity defined in the frontal mapping session (arm 1)
Experimental: HD-tDCS (anodal)
Subjects receive anodal tDCS over the personalized stipulation spot (arm 1) for a total of 18.75 minutes with an intensity of 2mA.
Active_comparator: HD-tDCS control (cathodal)
Subjects receive cathodal tDCS over the personalized stimulation spot (arm 1) for a total of 18.75 minutes with an intensity of 2mA.
Active_comparator: rTMS - Beam F3
Subjects receive active TMS over the Beam-F3 spot. All 3 TMS sessions follow the same protocol and procedures. The rTMS 10 Hz Dash protocol is applied for about 18.75 minutes with the individual intensity defined in the frontal mapping session (arm 1).
Related Therapeutic Areas
Sponsors
Leads: University of Bern
Collaborators: Universitäre Psychiatrische Dienste Bern (UPD), Switzerland, Medical School Berlin

This content was sourced from clinicaltrials.gov

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