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DepressionNCT04081519

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

A study testing active rTMS over DLPFC, Add-on active rTMS over DLPFC and Add-on active rTMS over LPC in people with Depression and Depressive Disorder, run by University Hospital, Bonn at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
active rTMS over DLPFC, Add-on active rTMS over DLPFC and Add-on active rTMS over LPC
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
53 participants
Where
1 siteGermany
Study dates
2 Aug 2016to 22 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • metal in the brain or the skull
  • cardiac pacemaker or intracardiac lines
  • medication infusion devices
  • heart or brain surgery
  • pregnancy
  • substance induced depression
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinik und Poliklinik für Psychiatrie und Psychotherapie

    Bonn

Other trials in Germany

About this study

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.

Being tested
active rTMS over DLPFC, Add-on active rTMS over DLPFC, Add-on active rTMS over LPC, Add-on sham rTMS
Keywords
Repetitive Transcranial Magnetic Stimulation, Theta Burst Stimulation, rTMS, TBS, resting-state fMRI, functional connectivity
Medical subject headings
Depression, Depressive Disorder, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active rTMS over DLPFCDevice

    15 sessions of active rTMS over DLPFC

  • Add-on active rTMS over DLPFCDevice

    15 additional sessions of active rTMS over DLPFC

  • Add-on active rTMS over LPCDevice

    15 additional sessions of active rTMS over LPC

  • Add-on sham rTMSDevice

    15 additional sessions of sham rTMS over DLPFC or LPC

Study groups in NCT04081519
Study groupRoleWhat they receive
DLPFC-DLPFCActive comparator15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over DLPFC
Receives: Device: active rTMS over DLPFC; Device: Add-on active rTMS over DLPFC
DLPFC-LPCExperimental15 sessions of active rTMS over DLPFC + 15 sessions of active rTMS over LPC
Receives: Device: active rTMS over DLPFC; Device: Add-on active rTMS over LPC
DLPFC-SHAMSham comparator15 sessions of active rTMS over DLPFC + 15 sessions of sham rTMS over DLPFC or LPC
Receives: Device: active rTMS over DLPFC; Device: Add-on sham rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 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

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

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

    Measured: 3 days prior to first rTMS session and 3 days after last rTMS session

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

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

    Measured: 3 days prior to first rTMS session and 3 days after last rTMS session

Secondary outcomes (7)

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

    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.

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

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

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

    Measured: 3 days prior to first rTMS session and 3 days after last rTMS session

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

    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.

    Measured: 3 days prior to first rTMS session and 3 days after last rTMS session

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

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

    Measured: 3 days prior to first rTMS session and 3 days after last rTMS session

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

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

    Measured: 3 days prior to first rTMS session and 3 days after last rTMS session

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

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

    Measured: 3 days prior to first rTMS session and 3 days after last rTMS session

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

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

    Measured: 3 days prior to first rTMS session and 3 days after last rTMS session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2019
  2. Study start2 Aug 2016
  3. Primary completion31 Mar 2018
  4. Study completion22 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04081519
Sponsor's protocol ID
SHIP
Status last verified
Jul 2021
First submitted
27 Aug 2019
Last updated
4 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. Biol Psychiatry. 2012 Oct 1;72(7):595-603. doi: 10.1016/j.biopsych.2012.04.028. Epub 2012 Jun 1.

    PubMed 22658708

  • Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900.

    PubMed 25170153

  • Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.

    PubMed 29726344

  • Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.

    PubMed 25034472

  • Daumann J, Fischermann T, Heekeren K, Henke K, Thron A, Gouzoulis-Mayfrank E. Memory-related hippocampal dysfunction in poly-drug ecstasy (3,4-methylenedioxymethamphetamine) users. Psychopharmacology (Berl). 2005 Aug;180(4):607-11. doi: 10.1007/s00213-004-2002-8. Epub 2005 Sep 14.

    PubMed 15372137

Questions about this trial

What is this clinical trial studying?

A study testing active rTMS over DLPFC, Add-on active rTMS over DLPFC and Add-on active rTMS over LPC in people with Depression and Depressive Disorder, run by University Hospital, Bonn at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04081519, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.

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