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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg
ClinicalTrials.gov Identifier:
NCT01460758
First received: October 21, 2011
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Depression
Device: Medial Frontal rTMS Double-Cone-Coil
Device: Left DLPFC Butterfly Coil
Device: Placebo Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Medial Frontal Repetitive Transcranial Magnetic Stimulation With Double-Cone-Coil in Patients With Major Depression

Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19) [ Time Frame: Day 19 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the Alertness (Baseline versus end of treatment/ day 19) [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19) [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
  • Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19) [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
  • Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19) [ Time Frame: Day 19 ] [ Designated as safety issue: No ]
  • Change in the Alertness (Baseline versus follow-up I/ day 47) [ Time Frame: Day 47 ] [ Designated as safety issue: No ]
  • Change in the Alertness (Baseline versus follow-up II/ day 75) [ Time Frame: Day 75 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47) [ Time Frame: Day 47 ] [ Designated as safety issue: No ]
  • Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75) [ Time Frame: Day 75 ] [ Designated as safety issue: No ]
  • Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47) [ Time Frame: Day 47 ] [ Designated as safety issue: No ]
  • Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75) [ Time Frame: Day 75 ] [ Designated as safety issue: No ]
  • Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47) [ Time Frame: Day 47 ] [ Designated as safety issue: No ]
  • Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75) [ Time Frame: Day 75 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: April 2011
Study Completion Date: November 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460758

Locations
Germany
University of Regensburg- Dept of Psychiatry
Regensburg, Germany
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Berthold Langguth, MD, Ph.D., Principal Investigator, University of Regensburg
ClinicalTrials.gov Identifier: NCT01460758     History of Changes
Other Study ID Numbers: Uni-Reg-ACDC01
Study First Received: October 21, 2011
Last Updated: April 25, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Regensburg:
Depression
Transcranial magnetic stimulation
rTMS
DLPFC
medial frontal cortex
anterior cingulate complex

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014