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

NCT01460758 | Completed

• 1 other identifier: Uni-Reg-ACDC01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Transcranial magnetic stimulation; rTMS; DLPFC; medial frontal cortex; anterior cingulate complex

Outcome Measures

Primary Outcomes (1)

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

  Day 19

Secondary Outcomes (15)

• Change in the Alertness (Baseline versus end of treatment/ 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)

  Day 19

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

  Day 19

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

  Day 19

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

  Day 19

Study Arms (3)

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.

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.

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

Device: Placebo Stimulation

Interventions

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.

Medial Frontal rTMS Double-Cone-Coil

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.

Left DLPFC Butterfly Coil

Placebo Stimulation DEVICE

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

Placebo Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

University of Regensburg- Dept of Psychiatry

Regensburg, Germany

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Berthold Langguth, MD

  University of Regensburg - Dep. of Psychiatry

  STUDY DIRECTOR

• Michael Landgrebe, MD

  University of Regensburg, Dpt of Psychiatry

  PRINCIPAL INVESTIGATOR

• Peter Kreuzer, MD

  University of Regensburg, Dpt of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 27, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

DE (1)