Clinical trial NCT05260086: Pre-mapping Networks for Brain Stimulation 2
Official title: Untersuchung Von Hirnnetzwerken Durch Nicht-invasive Transkranielle Magnetstimulation - Phase 2 (PreNeSt2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Episode
Major Depressive Disorder
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators compare study outcomes using aiTBS in personalized stimulation targets vs conventional F3 stimulation targets in parallel arms, each arm controlled by its respective sham stimulation in a counterbalanced crossover design.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale)
timeFrame: 6 weeks
measure: heart rate and its variability in RR slope and RMSSD values
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale)
timeFrame: 6 weeks
measure: Beck Depression Inventory (BDI-2 scores in units of scale)
timeFrame: 6 weeks
measure: DMN decoupling / other networks in rho and z values
timeFrame: 4-6 weeks
measure: epi / genetic markers of neuroplasticity in ng
timeFrame: 5-6 weeks
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIP-Lab Göttingen)
Study officials:
affiliation: University Medical Center Göttingen (UMG)
name: Roberto Goya-Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
References: