Pre-mapping Networks for Brain Stimulation 2 (PreNeSt2)

University Medical Center Goettingen

Status: Completed

Conditions: Major Depressive Disorder; Depressive Episode

Treatments: Device: Neuronavigated aiTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT05260086

01759

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups

Personalized aiTBS active - sham

Experimental group

Description:

counterbalanced crossover with sham neuronavigated stimulation

Treatment:

Device: Neuronavigated aiTBS

Conventional (F3) aiTBS active - sham

Active Comparator group

Description:

counterbalanced crossover with sham neuronavigated stimulation

Treatment:

Device: Neuronavigated aiTBS