Brain-oscillation Synchronised Stimulation of the Prefrontal Cortex

NCT02920840 | Completed

• 1 other identifier: BNP2016-03
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change from baseline in cortical excitability 30 minutes after the intervention

  TMS-evoked EEG potentials from left dlPFC

  30 minutes

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Change from baseline in mood on the Hamilton depression rating scale score 30 minutes after the intervention

  30 minutes

Study Arms (3)

Intermittent theta-burst stimulation

ACTIVE COMPARATOR

Intervention: application of 200 TMS triplet bursts (at 100 Hz, inter-burst interval 200ms) over left dorsolateral prefrontal cortex

Device: Intermittent theta-burst stimulation

Negative-peak-triggered-TMS

EXPERIMENTAL

Intervention: application of 200 brain-state dependent 100 Hz TMS triplet bursts triggered at the negative peak phase of the ongoing endogenous alpha-band oscillation (as detected by surface EEG over left dlPFC)

Device: Negative-peak-triggered-TMS

Open-loop replay TMS

ACTIVE COMPARATOR

Intervention: application of the same sequence of TMS pulses as in condition "Negative-peak-triggered-TMS", i.e. irrespective of ongoing brain state over left dlPFC

Device: Open-loop replay TMS

Interventions

Intermittent theta-burst stimulation DEVICE

see associated arm/group description

Intermittent theta-burst stimulation

Negative-peak-triggered-TMS DEVICE

see associated arm/group description

Negative-peak-triggered-TMS

Open-loop replay TMS DEVICE

see associated arm/group description

Open-loop replay TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are between 18 to 65 years old
• Subjects meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-4 criteria for current major depressive disorder (MDD), confirmed with the Structured Clinical Interview for DSM-4.
• On the 21-item Hamilton Rating Scale for Depression (HRSD) subjects need to score 8 points or more.
• Subject is in good physical and mental health. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
• Subject is willing to comply with the study restrictions.

You may not qualify if:

• Subject is under the age of legal consent.
• Subject suffers of bipolar disorder.
• Previous failure of nine or more electroconvulsive therapy treatments.
• A current major depressive episode longer than 5 years.
• A history of substance abuse or dependence within the past 2 years.
• Subject suffers of antisocial or borderline personality disorder, active suicidal ideation with plan and/or intent.
• Subject suffers of current symptoms of psychosis.
• Subject has a history of seizure disorder.
• Subject has a history of severe head injury with loss of consciousness.
• Subject had a prior brain surgery, or any other major psychiatric or medical comorbidity.
• Subjects with intake of pro-convulsive medication, e.g. imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, ecstasy, phencyclidine (PCP, angel's dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline, in accord with present consensus guidelines on safety, ethical considerations, and application of TMS in clinical practice and research (Rossi et al. 2009).
• Subjects are allowed to continue their antidepressant medication, but must be on that medication for at least 2 months and on a stable dose for at least 4 weeks (6 weeks in the case of fluoxetine). Drug doses have to be kept constant during the study.
• Patients with need of regular anxiolytic (e.g. benzodiazepine) treatment above 1 mg lorazepam/d.
• Subject has a cardiac pacemaker, implanted medication pump, intracardiac line, or acute, unstable cardiac disease.
• Subject has an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (excluding the mouth) that cannot be safely removed.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Neurology Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Brigitte Zrenner, MD

  University Neurology Hospital Tübingen

  STUDY DIRECTOR

• Florian Müller-Dahlhaus, MD

  University Neurology Hospital Tübingen

  STUDY DIRECTOR

• Ulf Ziemann, MD

  University Neurology Hospital Tübingen

  PRINCIPAL INVESTIGATOR

• Andreas J Fallgatter, MD

  University Psychiatry Hospital Tübingen

  PRINCIPAL INVESTIGATOR

• Surjo Soekadar, MD

  University Psychiatry Hospital Tübingen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 30, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 9, 2020

Record last verified: 2016-09

Locations

DE (1)