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

July 28, 2021 updated by: Rene Hurlemann, University Hospital, Bonn
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany
        • Klinik und Poliklinik für Psychiatrie und Psychotherapie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DLPFC-DLPFC
15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over DLPFC
Device: active rTMS over DLPFC
15 sessions of active rTMS over DLPFC
Device: Add-on active rTMS over DLPFC
15 additional sessions of active rTMS over DLPFC
Experimental: DLPFC-LPC
15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over LPC
Device: active rTMS over DLPFC
15 sessions of active rTMS over DLPFC
Device: Add-on active rTMS over LPC
15 additional sessions of active rTMS over LPC
Sham Comparator: DLPFC-SHAM
15 sessions of active rTMS over DLPFC + 15 sessions of sham rTMS over DLPFC or LPC
Device: active rTMS over DLPFC
15 sessions of active rTMS over DLPFC
Device: Add-on sham rTMS
15 additional sessions of sham rTMS over DLPFC or LPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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 days prior to first rTMS session and 3 days after last rTMS session
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.
3 days prior to first rTMS session and 3 days after last rTMS session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days prior to first rTMS session and 3 days after last rTMS session, follow-up after 4, 8 and 12 weeks
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 days prior to first rTMS session and 3 days after last rTMS session
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.
3 days prior to first rTMS session and 3 days after last rTMS session
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'.
3 days prior to first rTMS session and 3 days after last rTMS session
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.
3 days prior to first rTMS session and 3 days after last rTMS session
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.
3 days prior to first rTMS session and 3 days after last rTMS session
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.
3 days prior to first rTMS session and 3 days after last rTMS session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Collaborators

Clemens Mielacher, University Hospital, Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2016

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

June 22, 2018

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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