Pre-mapping Networks for Brain Stimulation 2

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Depressive Episode
• Interventions: Device: Neuronavigated aiTBS

• Registration Number: NCT05260086
• Lead Sponsor: University Medical Center Goettingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-03-02
• Status Verified: 2022-05
• Primary Completion: 2022-05-12
• Study Completion: 2022-05-12
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional (F3) aiTBS active - sham	Neuronavigated aiTBS	counterbalanced crossover with sham neuronavigated stimulation
Personalized aiTBS active - sham	Neuronavigated aiTBS	counterbalanced crossover with sham neuronavigated stimulation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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