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Completed

NCT Number: NCT01460758

Effectiveness of rTMS 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Regensburg- Dept of Psychiatry

Regensburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medial Frontal rTMS Double-Cone-Coil

Device

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 Coil

Device

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 stimulation

Device

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

Primary outcomes

  1. 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 outcomes

  1. Change in the Alertness (Baseline versus end of treatment/ day 19)

    Time frame: Day 19

  2. 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

  3. Change in the Beck Depression Inventory (Baseline versus end of treatment/ day 19)

    Time frame: Day 19

  4. Change in the Clinical Global Impression Scale (Baseline versus end of treatment/ day 19)

    Time frame: Day 19

  5. Change in the Global Assessment of Functioning scale (Baseline versus end of treatment/ day 19)

    Time frame: Day 19

  6. Change in the Alertness (Baseline versus follow-up I/ day 47)

    Time frame: Day 47

  7. Change in the Alertness (Baseline versus follow-up II/ day 75)

    Time frame: Day 75

  8. 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

  9. 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

  10. Change in the Beck Depression Inventory (Baseline versus follow-up I/ day 47)

    Time frame: Day 47

  11. Change in the Beck Depression Inventory (Baseline versus follow-up II/ day 75)

    Time frame: Day 75

  12. Change in the Clinical Global Impression Scale (Baseline versus follow-up I/ day 47)

    Time frame: Day 47

  13. Change in the Clinical Global Impression Scale (Baseline versus follow-up II/ day 75)

    Time frame: Day 75

  14. Change in the Global Assessment of Functioning scale (Baseline versus follow-up I/ day 47)

    Time frame: Day 47

  15. Change in the Global Assessment of Functioning scale (Baseline versus follow-up II/ day 75)

    Time frame: Day 75

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

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

Acronym: ACDC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 27, 2011
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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