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Completed

NCT Number: NCT05260086

Pre-mapping Networks for Brain Stimulation 2

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.

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Key information

Conditions

Depressive Episode Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Göttingen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale)

    Time frame: 6 weeks

    Administer Rating Scale

  2. heart rate and its variability in RR slope and RMSSD values

    Time frame: 4-6 weeks

    Potential marker of treatment response

Secondary outcomes

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

    Time frame: 6 weeks

    Administer Rating Scale

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

    Time frame: 6 weeks

    Self Rating Scale

  3. DMN decoupling / other networks in rho and z values

    Time frame: 4-6 weeks

    Potential markers of treatment response

  4. epi / genetic markers of neuroplasticity in ng

    Time frame: 5-6 weeks

    Potential markers of treatment response

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Official study title

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

Acronym: PreNeSt2

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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