Pre-mapping Networks for Brain Stimulation 2 (PreNeSt2)

Untersuchung Von Hirnnetzwerken Durch Nicht-invasive Transkranielle Magnetstimulation - Phase 2 (PreNeSt2)

The investigators compare the primary and secondary outcome measures using accelerated intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a counterbalanced crossover design) to treat depressive symptoms with 2 parallel arms of intervention: personalized (stimulation position based on participants' brain networks) vs conventional (stimulation in F3 position of the 10-20 EEG cap) aiTBS.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Depressive Episode
• Intervention / Treatment: Device: Neuronavigated aiTBS

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Göttingen, Germany
    • Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIP-Lab Göttingen)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women between the ages of 18 and 60 years
• Diagnosis of major depressive disorder according to DSM 5 (F32.x according to ICD-10) or bipolar disorder (bipolar I or bipolar II) according to DSM 5 (F31.x according to ICD-10) and an acute depressive condition at the time of the initial examination in outpatient or inpatient treatment (e.g. Department of Psychiatry and Psychotherapy, UMG)
• Availability of informed consent to participate in the study, including the examinations and interventions

Exclusion Criteria:

• Neurological diseases, current or previous
• Other Axis I diagnoses that mimic the affective disorder, current or previous
• Physical illnesses that could be related to the affective symptoms (so-called organic causes)
• Illicit drug use in the past month
• Substance dependence, current or previous
• Physical illnesses which, depending on their type and severity, could interfere with the planned examinations, influence the parameters to be examined or endanger the test participant during the course of the examination
• Medical contraindications against performing an MRT examination / rTMS application (such as metal parts in the body, e.g. implants, pacemakers, infusion pumps, metal splinters, etc.)
• Pregnancy
• Previously known cerebral-morphological abnormalities (e.g. tumor, lesion, etc.)
• Evidence or history of epilepsy
• Head trauma with a history of loss of consciousness
• Unwillingness to be informed of incidental findings
• Participation in an rTMS / EKT application within the last 8 weeks
• Lack of the ability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Personalized aiTBS active - sham; counterbalanced crossover with sham neuronavigated stimulation	Device: Neuronavigated aiTBS; Accelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC)
ACTIVE_COMPARATOR: Conventional (F3) aiTBS active - sham; counterbalanced crossover with sham neuronavigated stimulation	Device: Neuronavigated aiTBS; Accelerated intermittent theta burst stimulation (aiTBS, 4 sessions per day with at least 20 minutes pause between sessions) in the left dorsolateral prefrontal cortex (DLPFC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale)	Administer Rating Scale	6 weeks
heart rate and its variability in RR slope and RMSSD values	Potential marker of treatment response	4-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale)	Administer Rating Scale	6 weeks
Beck Depression Inventory (BDI-2 scores in units of scale)	Self Rating Scale	6 weeks
DMN decoupling / other networks in rho and z values	Potential markers of treatment response	4-6 weeks
epi / genetic markers of neuroplasticity in ng	Potential markers of treatment response	5-6 weeks

Collaborators and Investigators

• Sponsor: University Medical Center Goettingen
• Investigators: Principal Investigator: Roberto Goya-Maldonado, MD, University Medical Center Göttingen (UMG)

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): May 12, 2022
• Study Completion (ACTUAL): May 12, 2022

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (ACTUAL): March 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 01759

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No