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Pre-mapping Networks for Brain Stimulation 2 (PreNeSt2)

Primary Purpose

Depressive Episode, Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Neuronavigated aiTBS
Sponsored by
University Medical Center Goettingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Episode

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized aiTBS active - sham

Conventional (F3) aiTBS active - sham

Arm Description

counterbalanced crossover with sham neuronavigated stimulation

counterbalanced crossover with sham neuronavigated stimulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2021
Last Updated
May 12, 2022
Sponsor
University Medical Center Goettingen
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1. Study Identification

Unique Protocol Identification Number
NCT05260086
Brief Title
Pre-mapping Networks for Brain Stimulation 2
Acronym
PreNeSt2
Official Title
Untersuchung Von Hirnnetzwerken Durch Nicht-invasive Transkranielle Magnetstimulation - Phase 2 (PreNeSt2)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Goettingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Episode, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized aiTBS active - sham
Arm Type
Experimental
Arm Description
counterbalanced crossover with sham neuronavigated stimulation
Arm Title
Conventional (F3) aiTBS active - sham
Arm Type
Active Comparator
Arm Description
counterbalanced crossover with sham neuronavigated stimulation
Intervention Type
Device
Intervention Name(s)
Neuronavigated aiTBS
Intervention Description
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 Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale)
Description
Administer Rating Scale
Time Frame
6 weeks
Title
heart rate and its variability in RR slope and RMSSD values
Description
Potential marker of treatment response
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale)
Description
Administer Rating Scale
Time Frame
6 weeks
Title
Beck Depression Inventory (BDI-2 scores in units of scale)
Description
Self Rating Scale
Time Frame
6 weeks
Title
DMN decoupling / other networks in rho and z values
Description
Potential markers of treatment response
Time Frame
4-6 weeks
Title
epi / genetic markers of neuroplasticity in ng
Description
Potential markers of treatment response
Time Frame
5-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Goya-Maldonado, MD
Organizational Affiliation
University Medical Center Göttingen (UMG)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIP-Lab Göttingen)
City
Göttingen
Country
Germany

12. IPD Sharing Statement

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Pre-mapping Networks for Brain Stimulation 2

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