Allgemeine Informationen
  • Krankheitskategorie Grundlagenforschung (Anatomie/Physiologie) , Geistes- und Verhaltenskrankheiten , Erkrankungen des Nervensystems (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Bern
    (BASEC)
  • Studienverantwortliche Anna-Katharine Brem katy.brem@gmail.com (BASEC)
  • Datenquelle(n) BASEC: Import vom 01.05.2025 ICTRP: Import vom 20.03.2025
  • Letzte Aktualisierung 01.05.2025 06:36
HumRes66121 | SNCTP000006188 | BASEC2024-D0080 | NCT06748274

The brain-heart-gut connection: targeted modulation of the frontal-vagal network for the personalization of non-invasive brain stimulation

  • Krankheitskategorie Grundlagenforschung (Anatomie/Physiologie) , Geistes- und Verhaltenskrankheiten , Erkrankungen des Nervensystems (BASEC)
  • Studienphase N/A (ICTRP)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Bern
    (BASEC)
  • Studienverantwortliche Anna-Katharine Brem katy.brem@gmail.com (BASEC)
  • Datenquelle(n) BASEC: Import vom 01.05.2025 ICTRP: Import vom 20.03.2025
  • Letzte Aktualisierung 01.05.2025 06:36

Zusammenfassung der Studie

Depression often occurs alongside cardiovascular and gastrointestinal symptoms, highlighting the importance of the brain-heart-gut axis in pathophysiology and treatment. Studies show that central structures in the depression network, such as the dorsolateral prefrontal cortex (DLPFC) and the subgenual anterior cingulate cortex (sgACC), overlap with areas involved in autonomic control, the vagus nerve. Although repetitive transcranial magnetic stimulation (rTMS) of the DLPFC is an established treatment method, optimal targeting remains a challenge. Personalized stimulation based on the connectivity between DLPFC and sgACC may improve treatment success but has so far been only limitedly applicable in clinical settings. rTMS-induced brain-heart coupling (HBC) offers a new approach to determine the target based on heart rate responses. The aim of this project is to personalize HBC to optimize targeting of the DLPFC and investigate further indicators of the frontal-vagal network. In study arm 1, we use a new frontal mapping technique to identify the personalized “Grid-Spot” that elicits the strongest HBC in healthy individuals. We compare the effects of a 10Hz “Dash” protocol over the “Grid-Spot” with the conventional “Beam-F3” method and a control region (Cz), while measuring additional parameters of the autonomic nervous system (ANS) such as gut motility, pupil dilation, and electrodermal activity. This methodology will also be extended to the application of high-definition transcranial direct current stimulation (HD-tDCS). We investigate the effects of anodic versus sham HD-tDCS over the HBC-based “Grid-Spot” on ANS parameters and compare these with the rTMS effects. In study arm 2, we repeat the rTMS experiments from arm 1 in individuals with increased depressive and ANS symptomatology.

(BASEC)

Untersuchte Intervention

TMS: Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method, where targeted magnetic field pulses can modulate neuronal activity in specific brain areas. The aim of this study is to investigate the coupling between the brain and the heart to determine an individualized stimulation point above the dorsolateral prefrontal cortex. This intervention will be applied in a total of 6 sessions. The first session serves to localize the stimulation point and determine the stimulation intensity. In the following three sessions, this point and two other points will be stimulated for 18.75 minutes, and their effects on the heart and other organs will be examined. The order of sessions will be random.

 

TDCS: Transcranial direct current stimulation is another non-invasive method of brain stimulation, where the application of electric current to the head induces a change in neuronal activity in the underlying brain areas. In two sessions, stimulation will be applied for 18.75 minutes over the individual stimulation point. One session will serve as a control intervention, where no real stimulation occurs. Neither you nor the study leaders know the order of the protocol (random). Following the 18.75-minute tDCS stimulation, TMS will again be applied for 4 minutes to investigate the effects on brain-heart coupling.

(BASEC)

Untersuchte Krankheit(en)

Participants with gastrointestinal and concurrent depressive symptoms (Arm 2), as well as healthy subjects (Arm 1)

(BASEC)

Kriterien zur Teilnahme
Study arm 1: - Healthy adult participants aged 18 to 65 years - Willingness to participate and signed consent. - Normal or corrected vision, as well as normal hearing ability Study arm 2: Same criteria as study arm 1 with the addition of - Elevated scores on the “Patient Health Care” questionnaire (PHQ-9) - Elevated scores on the “Composite Autonomic Symptom Score” questionnaire (COMPASS-31) - Signs of functional dyspepsia (BASEC)

Ausschlusskriterien
- Existing history of brain injuries, neurological or other psychiatric illnesses (e.g., stroke, traumatic brain injury, schizophrenia, epilepsy, etc.). - Presence of metal in the head and/or medical implants (e.g., pacemaker) - Substance abuse, excessive alcohol consumption and/or use of psychoactive medication (e.g., sleeping pills) (BASEC)

Studienstandort

Bern

(BASEC)

Switzerland (ICTRP)

Sponsor

University Hospital of Old Age Psychiatry and Psychotherapy (UPD)

(BASEC)

Kontakt für weitere Auskünfte zur Studie

Kontaktperson Schweiz

Anna-Katharine Brem

+41 79 364 1999

katy.brem@gmail.com

University Hospital of Old Age Psychiatry and Psychotherapy (UPD)

(BASEC)

Allgemeine Auskünfte

University Hospiltal of Old Age Psychiatry and Psychotherapy,

+41586306880

katy.brem@gmail.com

(ICTRP)

Allgemeine Auskünfte

University Hospiltal of Old Age Psychiatry and Psychotherapy

+41586306880

katy.brem@gmail.com

(ICTRP)

Wissenschaftliche Auskünfte

University Hospiltal of Old Age Psychiatry and Psychotherapy,

+41586306880

katy.brem@gmail.com

(ICTRP)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Bern

(BASEC)

Datum der Bewilligung durch die Ethikkommission

22.11.2024

(BASEC)


ICTRP Studien-ID
NCT06748274 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
The Brain-Heart-Gut Connection (BHG-CONNECT) (BASEC)

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

Öffentlicher Titel
The Brain-Heart-Gut Connection (ICTRP)

Untersuchte Krankheit(en)
Major DepressionFunctional DyspepsiaAutonomous Dysfunction (ICTRP)

Untersuchte Intervention
Device: Transcranial Magnetic Stimulation (TMS)Device: High-definition transcranial direct current stimulation (HD-tDCS) (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)

Ein-/Ausschlusskriterien
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 (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Heart rate;Heart Rate Variability (ICTRP)

Heart Rate Variability;Gut Motility (GM);Heart rate;Pupil dilation;Salivary cortisol;Salivary a-amylase;Electrodermal activity (EDA) (ICTRP)

Registrierungsdatum
10.12.2024 (ICTRP)

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
Medical School Berlin;Universit�re Psychiatrische Dienste Bern (UPD), Switzerland (ICTRP)

Weitere Kontakte
Anna-Katharine Brem, PD Dr.;Jessica Jacobs, Msc, Jessica.jacobs@unibe.ch, +41586306880, University Hospiltal of Old Age Psychiatry and Psychotherapy, (ICTRP)

Sekundäre IDs
2024-D0080, BHG-CONNECT (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06748274 (ICTRP)


Ergebnisse der Studie

Zusammenfassung der Ergebnisse

nicht verfügbar

Link zu den Ergebnissen im Primärregister

nicht verfügbar