Pre-mapping Networks for Brain Stimulation 2

NCT05260086 | Completed

• 1 other identifier: 01759
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Episode; Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale)

  6 weeks

• Beck Depression Inventory (BDI-2 scores in units of scale)

  6 weeks

• DMN decoupling / other networks in rho and z values

  4-6 weeks

• epi / genetic markers of neuroplasticity in ng

  5-6 weeks

Study Arms (2)

Personalized aiTBS active - sham

EXPERIMENTAL

counterbalanced crossover with sham neuronavigated stimulation

Device: Neuronavigated aiTBS

Conventional (F3) aiTBS active - sham

ACTIVE COMPARATOR

counterbalanced crossover with sham neuronavigated stimulation

Device: Neuronavigated aiTBS

Interventions

Neuronavigated aiTBS DEVICE

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)

Conventional (F3) aiTBS active - sham; Personalized aiTBS active - sham

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

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

Göttingen, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Roberto Goya-Maldonado, MD

  University Medical Center Göttingen (UMG)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: March 2, 2022
• Study Start: April 15, 2019
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

DE (1)