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PreNeSt2: Pre-mapping Networks for Brain Stimulation 2

Sponsor
University Medical Center Goettingen (Other)
Overall Status
Completed
CT.gov ID
NCT05260086
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
36.9
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Neuronavigated aiTBS
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Untersuchung Von Hirnnetzwerken Durch Nicht-invasive Transkranielle Magnetstimulation - Phase 2 (PreNeSt2)
Actual Study Start Date :
Apr 15, 2019
Actual Primary Completion Date :
May 12, 2022
Actual Study Completion Date :
May 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Personalized aiTBS active - sham

counterbalanced crossover with sham neuronavigated stimulation

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)
Active Comparator: Conventional (F3) aiTBS active - sham

counterbalanced crossover with sham neuronavigated stimulation

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)

Outcome Measures

Primary Outcome Measures

  1. Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale) [6 weeks]

    Administer Rating Scale

  2. heart rate and its variability in RR slope and RMSSD values [4-6 weeks]

    Potential marker of treatment response

Secondary Outcome Measures

  1. Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale) [6 weeks]

    Administer Rating Scale

  2. Beck Depression Inventory (BDI-2 scores in units of scale) [6 weeks]

    Self Rating Scale

  3. DMN decoupling / other networks in rho and z values [4-6 weeks]

    Potential markers of treatment response

  4. epi / genetic markers of neuroplasticity in ng [5-6 weeks]

    Potential markers of treatment response

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laboratory of Systems Neuroscience and Imaging in Psychiatry (SNIP-Lab Göttingen) Göttingen Germany

Sponsors and Collaborators

  • University Medical Center Goettingen

Investigators

  • Principal Investigator: Roberto Goya-Maldonado, MD, University Medical Center Göttingen (UMG)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PD Dr. Roberto Goya-Maldonado, Principal Investigator, University Medical Center Goettingen
ClinicalTrials.gov Identifier:
NCT05260086
Other Study ID Numbers:
  • 01759
First Posted:
Mar 2, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
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
Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major

Study Results

No Results Posted as of May 19, 2022