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Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep

NCT04832750 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2024-12-11

No results posted yet for this study

Summary

Advances in repetitive transcranial magnetic stimulation (rTMS) protocols with intermittent theta-burst stimulation (iTBS) have significantly decreased the duration for one single session and thereby enabled accelerated treatment plans with multiple sessions per day, potentially reducing the total treatment duration. This randomized, placebo-controlled study investigates the effects of accelerated iTBS treatment with connectivity-informed neuronavigation on symptom severity, sleep, interoception, and cognitive control in patients with major depressive disorder and with or without comorbid borderline personality disorder using magnetic resonance imaging (MRI).

Conditions

Interventions

DEVICE

intermittent theta burst stimulation (iTBS) or sham stimulation

30 sessions of iTBS over 2 weeks (3 sessions per day, 5 days per week)

Sponsors & Collaborators

  • Marc Onken, M.Sc.

    collaborator UNKNOWN

  • Christina Mueller, M.Sc.

    collaborator UNKNOWN

  • University of Oldenburg

    lead OTHER

Principal Investigators

  • René Hurlemann, Prof. · Department of Psychiatry, University of Oldenburg

  • Dirk Scheele, Dr. · Department of Psychiatry, University of Oldenburg

  • Christina Mueller, M.Sc. · Department of Psychiatry, University of Oldenburg

  • Marc Onken, M.Sc. · Department of Psychiatry, University of Oldenburg

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2024-06-14
Completion
2024-07-26

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04832750 on ClinicalTrials.gov