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Completed

NCT Number: NCT04081519

Stimulation of Parieto-hippocampal Connectivity in Patients With Major Depressive Disorder

This study aims to investigate the effects of individualized repetitive transcranial magnetic stimulation (rTMS) of parieto-hippocampal functional connectivity in patients with major depressive disorder (MDD). Specifically, patients will be randomized to one of three groups and will receive 15 days of rTMS over three weeks. Each day they will receive one active session of rTMS over the dorsolateral parietal cortex (DLPFC) and depending on group assignment another session either A) active rTMS over DLPFC, B) active rTMS over left and right lateral parietal cortex (LPC), or C) sham rTMS over DLPFC or LPC. Stimulation targets in the LPC will be individualized for each patient based on their resting-state functional connectivity between the hippocampus and LPC. Clinical, neuropsychological and fMRI data will be acquired before and after the treatment course.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Depressive Episode Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik und Poliklinik für Psychiatrie und Psychotherapie

Bonn, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • fulfilled criteria for unipolar major depressive disorder for at least four weeks
  • did not respond to a minimum of one or did not tolerate a minimum of two antidepressants in the current episode

Exclusion criteria

  • metal in the brain or the skull
  • cardiac pacemaker or intracardiac lines
  • medication infusion devices
  • heart or brain surgery
  • pregnancy
  • substance induced depression
  • history of substance abuse
  • psychotic episodes
  • bipolar disorder
  • anorexia
  • posttraumatic stress disorder (current or within the last 12 months)
  • claustrophobia
  • any condition resulting in increased intracranial pressure
  • traumatic brain injury
  • history of epilepsy
  • cerebral aneurysms
  • dementia
  • Morbus Parkinson
  • Chorea Huntington
  • multiple sclerosis
  • stroke or transient ischemic attack (within the last 2 years)
  • previous antidepressive treatment with rTMS, electroconvulsive therapy (within the last 3 months), vagus nerve stimulation or deep brain stimulation

Treatment and study plan

active rTMS over DLPFC

Device

15 sessions of active rTMS over DLPFC

Add-on active rTMS over DLPFC

Device

15 additional sessions of active rTMS over DLPFC

Add-on active rTMS over LPC

Device

15 additional sessions of active rTMS over LPC

Add-on sham rTMS

Device

15 additional sessions of sham rTMS over DLPFC or LPC

Primary outcomes

  1. Change in depression severity as measured by the Hamilton Depression Rating Scale (HAMD-17)

    Time frame: Four measurement time points with a seven-day interval starting on the first day of stimulation, and ending three days after the last day of stimulation

    Remission defined as HAMD-17 score (range: 0 to 52, lower scores represent better outcome) of less than or equal to 8 after the rTMS course. Response defined as a reduction of at least 50% from baseline in HAMD-17 score after treatment.

  2. Change in functional connectivity coefficients based on resting-state fMRI

    Time frame: 3 days prior to first rTMS session and 3 days after last rTMS session

    Seed-to-voxel and ROI-to-ROI functional connectivity analysis of rs-fMRI data.

  3. Change in task-based fMRI activation during associative memory paradigm

    Time frame: 3 days prior to first rTMS session and 3 days after last rTMS session

    Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal encoding and retrieval with a focus on hippocampal regions.

Secondary outcomes

  1. Change in depression severity as measured by the Beck's Depression Inventory (BDI-II)

    Time frame: 3 days prior to first rTMS session and 3 days after last rTMS session, follow-up after 4, 8 and 12 weeks

    Remission defined as BDI-II score (range: 0 to 63, lower scores represent better outcome) of less than or equal to 12 after the rTMS course. Response defined as a reduction of at least 50% from baseline in BDI-II score after treatment.

  2. Change in visual memory as assessed by the Delayed Matching to Sample test (DMS)

    Time frame: 3 days prior to first rTMS session and 3 days after last rTMS session

    Subjects will be assessed in the domain of visual memory by undergoing computorized neurological testing. Outcome varible is percentage of correct answers.

  3. Change in spatial planning as assessed by the One Touch Stockings of Cambridge (OTS)

    Time frame: 3 days prior to first rTMS session and 3 days after last rTMS session

    Subjects will be assessed in the domain of spatial planning by undergoing computorized neurological testing. Outcome varible is the mean number of choices to correct answer.

  4. Change in visual sustained attention as assessed by the Rapid Visual Information Processing (RVP)

    Time frame: 3 days prior to first rTMS session and 3 days after last rTMS session

    Subjects will be assessed in the domain of visual sustained attention by undergoing computorized neurological testing. Outcome varible is the target sensitivity A'.

  5. Change in working memory as assessed by the Spatial Working Memory (SWM)

    Time frame: 3 days prior to first rTMS session and 3 days after last rTMS session

    Subjects will be assessed in the domain of working memory by undergoing computorized neurological testing. Outcome varible is the total number of errors.

  6. Change in task-based fMRI activation during social touch paradigm

    Time frame: 3 days prior to first rTMS session and 3 days after last rTMS session

    Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal while participants receive tactile stimulation.

  7. Change in task-based fMRI activation during emotional processing paradigm

    Time frame: 3 days prior to first rTMS session and 3 days after last rTMS session

    Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal while participants perform an emotional processing task.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2019
Registry last updated
Aug 4, 2021

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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