Pre-mapping Networks for Brain Stimulation 2

Major Depressive Disorder Clinical Trial

— PreNeSt2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260086
• Other study ID #: 01759
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: May 12, 2022

Study information

• Verified date: May 2022
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: May 12, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Depressive Episode
• Major Depressive Disorder

Intervention

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)

Locations

Country	Name	City	State
Germany	Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIP-Lab Göttingen)	Göttingen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale)	Administer Rating Scale	6 weeks
Primary	heart rate and its variability in RR slope and RMSSD values	Potential marker of treatment response	4-6 weeks
Secondary	Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale)	Administer Rating Scale	6 weeks
Secondary	Beck Depression Inventory (BDI-2 scores in units of scale)	Self Rating Scale	6 weeks
Secondary	DMN decoupling / other networks in rho and z values	Potential markers of treatment response	4-6 weeks
Secondary	epi / genetic markers of neuroplasticity in ng	Potential markers of treatment response	5-6 weeks