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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Medial Frontal rTMS Double-Cone-Coil
Left DLPFC Butterfly Coil
Placebo Stimulation
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Transcranial magnetic stimulation, rTMS, DLPFC, medial frontal cortex, anterior cingulate complex

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Regensburg- Dept of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Medial Frontal rTMS Double-Cone-Coil

Left DLPFC Butterfly Coil

Placebo Stimulation

Arm Description

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.

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 Stimulation (Conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz,2000 Stimuli each session, 110% motor threshold

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 21, 2011
Last Updated
April 25, 2014
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT01460758
Brief Title
Effectiveness of rTMS With Double-Cone-Coil in Patients With Major Depression
Acronym
ACDC
Official Title
Effectiveness of Medial Frontal Repetitive Transcranial Magnetic Stimulation With Double-Cone-Coil in Patients With Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Transcranial magnetic stimulation, rTMS, DLPFC, medial frontal cortex, anterior cingulate complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medial Frontal rTMS Double-Cone-Coil
Arm Type
Experimental
Arm Description
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.
Arm Title
Left DLPFC Butterfly Coil
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Stimulation
Arm Type
Sham Comparator
Arm Description
Sham Stimulation (Conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz,2000 Stimuli each session, 110% motor threshold
Intervention Type
Device
Intervention Name(s)
Medial Frontal rTMS Double-Cone-Coil
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Left DLPFC Butterfly Coil
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo Stimulation
Intervention Description
Sham Stimulation (conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz, 2000 Stimuli each session, 110% motor threshold
Primary Outcome Measure Information:
Title
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)
Time Frame
Day 19
Secondary Outcome Measure Information:
Title
Change in the Alertness (Baseline versus end of treatment/ day 19)
Time Frame
Day 19
Title
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
Title
Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19)
Time Frame
Day 19
Title
Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19)
Time Frame
Day 19
Title
Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19)
Time Frame
Day 19
Title
Change in the Alertness (Baseline versus follow-up I/ day 47)
Time Frame
Day 47
Title
Change in the Alertness (Baseline versus follow-up II/ day 75)
Time Frame
Day 75
Title
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
Title
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
Title
Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47)
Time Frame
Day 47
Title
Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75)
Time Frame
Day 75
Title
Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47)
Time Frame
Day 47
Title
Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75)
Time Frame
Day 75
Title
Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47)
Time Frame
Day 47
Title
Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75)
Time Frame
Day 75

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, MD
Organizational Affiliation
University of Regensburg - Dep. of Psychiatry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Landgrebe, MD
Organizational Affiliation
University of Regensburg, Dpt of Psychiatry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Kreuzer, MD
Organizational Affiliation
University of Regensburg, Dpt of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Regensburg- Dept of Psychiatry
City
Regensburg
Country
Germany

12. IPD Sharing Statement

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

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