Effectiveness of rTMS With Double-Cone-Coil in Patients With Major Depression (ACDC)

April 25, 2014 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

Effectiveness of Medial Frontal Repetitive Transcranial Magnetic Stimulation With Double-Cone-Coil in Patients With Major Depression

Repetitive Transcranial Magnetic Stimulation (rTMS) is used to modulate the neuronal excitability in patients with depression. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be superior to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is a common mental disorder that presents with depressed mood, loss of interest, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy levels and poor concentration. These problems can become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday's responsibilities, at its worst, depression can lead to suicide. Depression can be reliably diagnosed in primary care. Antidepressant medications and brief, structured forms of psychotherapy are effective for 60-80% of those affected and can be delivered in primary care.

In patients with depression the cerebral metabolism is deranged in some specific areas such as hypoexcitability in frontal cortical areas. High-frequency rTMS of the dorsolateral prefrontal cortex (DLPFC) has been investigated for the treatment of hypoexcitability disorders. Mild antidepressant effects of rTMS applied to the left sided dorsolateral prefrontal cortex (DLPFC) using a standard butterfly coil can possibly be increased by a different stimulation protocol over the medial frontal cortex using a double-cone-coil. First hints to effectiveness of this treatment arise from case reports and therefore need replication and comparability to conventional stimulation protocols. In the present study the investigators will examine whether medial frontal rTMS using a double-cone-coil proves to be more effective to conventional high-frequency-rTMS applied to the left-sided prefrontal cortex with a butterfly-coil.

Study Type

Interventional

Enrollment (Actual)

45

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
      • Regensburg, Germany
        • University of Regensburg- Dept of Psychiatry

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Episode of depression (unipolar or bipolar)( ICD-10)
  • Female or male between 18 and 70 years old
  • Skills to participate in all study procedures
  • 18 or more points in the Hamilton rating scale or depression
  • Stable antidepressant drugs
  • Written informed consent

Exclusion Criteria:

  • Clinically relevant unstable internal or neurological comorbidity
  • Evidence of significant brain malformations or neoplasm, head injury
  • Cerebral vascular events
  • Neurodegenerative disorders affecting the brain or prior brain surgery
  • Metal objects in and around body that can not be removed
  • Pregnancy
  • Alcohol or drug abuse
  • Epilepsy or a pathological EEG
  • Heart pacemaker
  • High dose tranquillizers

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Medial Frontal rTMS Double-Cone-Coil
High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodmann area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold.
Device: Medial Frontal rTMS Double-Cone-Coil
High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodmann area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold.
EXPERIMENTAL: Left DLPFC Butterfly Coil
High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 10 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold.
Device: Left DLPFC Butterfly Coil
High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 10 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold.
SHAM_COMPARATOR: Placebo Stimulation
Sham Stimulation (Conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz,2000 Stimuli each session, 110% motor threshold
Device: Placebo Stimulation
Sham Stimulation (conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz, 2000 Stimuli each session, 110% motor threshold

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)
Time Frame: Day 19
Day 19

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the Alertness (Baseline versus end of treatment/ day 19)
Time Frame: Day 19
Day 19
Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19)
Time Frame: Day 19
Day 19
Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19)
Time Frame: Day 19
Day 19
Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19)
Time Frame: Day 19
Day 19
Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19)
Time Frame: Day 19
Day 19
Change in the Alertness (Baseline versus follow-up I/ day 47)
Time Frame: Day 47
Day 47
Change in the Alertness (Baseline versus follow-up II/ day 75)
Time Frame: Day 75
Day 75
Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up I/ day 47)
Time Frame: Day 47
Day 47
Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up II/ day 75)
Time Frame: Day 75
Day 75
Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47)
Time Frame: Day 47
Day 47
Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75)
Time Frame: Day 75
Day 75
Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47)
Time Frame: Day 47
Day 47
Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75)
Time Frame: Day 75
Day 75
Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47)
Time Frame: Day 47
Day 47
Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75)
Time Frame: Day 75
Day 75

Collaborators and Investigators

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

Sponsor

University of Regensburg

Investigators

  • Study Director: Berthold Langguth, MD, University of Regensburg - Dep. of Psychiatry
  • Principal Investigator: Michael Landgrebe, MD, University of Regensburg, Dpt of Psychiatry
  • Principal Investigator: Peter Kreuzer, MD, University of Regensburg, Dpt of Psychiatry

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

April 1, 2011

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (ESTIMATE)

October 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Reg-ACDC01

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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