DepressionACDCNCT01460758
Effectiveness of rTMS With Double-Cone-Coil in Patients With Major Depression
A study testing Medial Frontal rTMS Double-Cone-Coil and Left DLPFC Butterfly Coil in people with Depression, run by University of Regensburg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- What is being tested?
- Medial Frontal rTMS Double-Cone-Coil and Left DLPFC Butterfly Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Alcohol or drug abuse
- Epilepsy or a pathological EEG
- Heart pacemaker
- High dose tranquillizers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- Medial Frontal rTMS Double-Cone-Coil, Left DLPFC Butterfly Coil, Placebo Stimulation
- Keywords
- Depression, Transcranial magnetic stimulation, rTMS, DLPFC, medial frontal cortex, anterior cingulate complex
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial Frontal rTMS Double-Cone-CoilDevice
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.
Left DLPFC Butterfly CoilDevice
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.
Placebo StimulationDevice
Sham Stimulation (conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz, 2000 Stimuli each session, 110% motor threshold
| Study group | Role | What they receive |
|---|---|---|
| Medial Frontal rTMS Double-Cone-Coil | Experimental | 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. Receives: Device: Medial Frontal rTMS Double-Cone-Coil |
| Left DLPFC Butterfly Coil | Experimental | 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. Receives: Device: Left DLPFC Butterfly Coil |
| Placebo Stimulation | Sham comparator | Sham Stimulation (Conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz,2000 Stimuli each session, 110% motor threshold Receives: Device: Placebo Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)
Measured: Day 19
Secondary outcomes (15)
Change in the Alertness (Baseline versus end of treatment/ day 19)
Measured: Day 19
Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus end of treatment/ day 19)
Measured: Day 19
Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19)
Measured: Day 19
Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19)
Measured: Day 19
Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19)
Measured: Day 19
Change in the Alertness (Baseline versus follow-up I/ day 47)
Measured: Day 47
Change in the Alertness (Baseline versus follow-up II/ day 75)
Measured: Day 75
Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up I/ day 47)
Measured: Day 47
Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (Baseline versus follow-up II/ day 75)
Measured: Day 75
Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47)
Measured: Day 47
Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75)
Measured: Day 75
Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47)
Measured: Day 47
Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75)
Measured: Day 75
Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47)
Measured: Day 47
Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75)
Measured: Day 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, MD, Study director, University of Regensburg - Dep. of PsychiatryMichael Landgrebe, MD, Principal investigator, University of Regensburg, Dpt of PsychiatryPeter Kreuzer, MD, Principal investigator, University of Regensburg, Dpt of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460758
- Sponsor's protocol ID
- Uni-Reg-ACDC01
- Acronym
- ACDC
- Status last verified
- Apr 2014
- First submitted
- 21 Oct 2011
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Medial Frontal Repetitive Transcranial Magnetic Stimulation With Double-Cone-Coil in Patients With Major Depression
- ClinicalTrials.gov ID
- NCT01460758
- Acronym / sponsor ID
- ACDC / Uni-Reg-ACDC01
- Conditions
- Depression
- Keywords
- Depression, Transcranial magnetic stimulation, rTMS, DLPFC, medial frontal cortex, anterior cingulate complex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medial Frontal rTMS Double-Cone-Coil | Experimental | Device: Medial Frontal rTMS Double-Cone-CoilHigh 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. |
| Left DLPFC Butterfly Coil | Experimental | Device: Left DLPFC Butterfly CoilHigh 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. |
| Placebo Stimulation | Sham comparator | Device: Placebo StimulationSham Stimulation (Conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz,2000 Stimuli each session, 110% motor threshold |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medial Frontal rTMS Double-Cone-CoilHigh 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 |
| Left DLPFC Butterfly CoilHigh 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 |
| Placebo StimulationSham Stimulation (conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz, 2000 Stimuli each session, 110% motor threshold | Device | Placebo Stimulation |
Primary outcome
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19)
Time frame: Day 19
15 secondary outcomes
Change in the Alertness (Baseline versus end of treatment/ day 19)
Time frame: 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
Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19)
Time frame: Day 19
Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19)
Time frame: Day 19
Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19)
Time frame: Day 19
Change in the Alertness (Baseline versus follow-up I/ day 47)
Time frame: Day 47
Change in the Alertness (Baseline versus follow-up II/ day 75)
Time frame: 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
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
Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47)
Time frame: Day 47
Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75)
Time frame: Day 75
Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47)
Time frame: Day 47
Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75)
Time frame: Day 75
Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47)
Time frame: Day 47
Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75)
Time frame: Day 75
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Langguth, MD study director
University of Regensburg - Dep. of Psychiatry
Michael Landgrebe, MD principal investigator
University of Regensburg, Dpt of Psychiatry
Peter Kreuzer, MD principal investigator
University of Regensburg, Dpt of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medial Frontal rTMS Double-Cone-Coil and Left DLPFC Butterfly Coil in people with Depression, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (Baseline versus end of treatment/ day 19) (time frame: Day 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.