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Clinical Trials/NCT02920840
NCT02920840
Completed
Not Applicable

Brain-oscillation Synchronised Stimulation of the Prefrontal Cortex: Development and Validation of a Personalized Closed-loop TMS Protocol for the Treatment of Major Depression

University Hospital Tuebingen1 site in 1 country17 target enrollmentSeptember 2016
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University Hospital Tuebingen
Enrollment
17
Locations
1
Primary Endpoint
Change from baseline in cortical excitability 30 minutes after the intervention
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Combining TMS and EEG, this study investigates a personalized therapeutic non-invasive brain stimulation protocol in patients with major depression, whereby the timing of the TMS pulses is synchronized with the instantaneous phase of ongoing brain oscillations in order to modulate the inter-hemispheric left and right dorso-lateral prefrontal cortical brain network.

Detailed Description

Major depressive disorder is a severe psychiatric illness with a lifetime prevalence of about 8-16%. Many patients fail to achieve complete remission of symptoms under antidepressant medication, with about 10% of patients being chronically resistant to several psychopharmacological treatments. Development of alternative non-pharmacological treatments is therefore essential to improve patient care. Repetitive transcranial magnetic stimulation (rTMS) offers therapeutic potential in this context. Current protocols apply high-frequency rTMS over left dorsolateral prefrontal cortex (DLPFC) to reverse the increased alpha-band oscillatory activity and cortical hypo-excitability in patients with depression. However, translation of rTMS therapy into routine clinical practice has been limited due to low efficacy and high inter-individual variability. This study aims to optimize rTMS stimulation protocols for MDD by deterministically coupling the timing of TMS to the ongoing oscillatory neural activity in the underlying cortex as measured in real-time with high-density surface EEG. It is hypothesized that alpha phase-locked rTMS of the left DLPFC reverses increased alpha-band oscillatory activity and cortical hypo-excitability more efficiently than current open-loop rTMS protocols used in the treatment of MDD.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
April 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline in cortical excitability 30 minutes after the intervention

Time Frame: 30 minutes

TMS-evoked EEG potentials from left dlPFC

Secondary Outcomes

  • Change from baseline in EEG alpha power 30 minutes after the intervention(30 minutes)
  • Change from baseline in verbal working memory performance 30 minutes after the intervention(30 minutes)

Study Sites (1)

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