The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham

NCT ID: NCT00622947

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-02-28

Brief Summary

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The aim of the present study is to compare the antidepressant effect of low frequency rTMS applied over the right temporal cortex with sham stimulation.

Detailed Description

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TMS complies focal stimulation of the brain through a time varying magnetic field. Clinical controlled trials indicate that rTMS of the dorsolateral prefrontal cortex may have an antidepressant effect and no serious side effects. Several clinical controlled studies investigating the antidepressant effect of low as well as high frequency rTMS of the right and left prefrontal cortex have been carried out with varying results.Research on the issue suffer from small and selected study populations.There is a need for additional clinical controlled studies on larger samples and methodological investigations to clarify what is the optimal stimulus design for the treatment of depressed patients.

Recent research indicates that Depression is associated with an increased metabolic activity of subcortical areas especially the right hippocampus of the brain.

Remission of depression symptoms is associated with normalisation of the described subcortical hyperactivity.

Low frequency rTMS has shown to be associated with sustained reduction in neuronal activity.

There may be an association between the activity decreasing effect of low frequency rTMS and reduction in psychiatric symptoms.

The investigators want to test the hypothesis that low frequency rTMS of the right temporal subcortical areas (Hippocampus and and the parahippocampal part of CNS) may perform an antidepressant effect by normalizing the described hyperactivity of the subcortical areas in depressed patients.

In addition the investigators want to test whether blood concentration of Brain Derived Neurotropic Factor( BDNF), the BDNF-genotype and saliva cortisol may be of predictive value in depressed patients.

Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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repetitive transcranial magnetic stimulation

Low frequency ( 1 HZ) rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.

Group Type ACTIVE_COMPARATOR

right temporal low frequency (1 hz) rTMS

Intervention Type PROCEDURE

Right temporal low frequency (1 hz) rTMS.

Placebo stimulation

Sham- rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval.

Group Type SHAM_COMPARATOR

Sham-rTMS

Intervention Type PROCEDURE

The coil is angled 90 degrees away from the scalp

Interventions

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right temporal low frequency (1 hz) rTMS

Right temporal low frequency (1 hz) rTMS.

Intervention Type PROCEDURE

Sham-rTMS

The coil is angled 90 degrees away from the scalp

Intervention Type PROCEDURE

Other Intervention Names

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A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular coil is used.

Eligibility Criteria

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Inclusion Criteria

* Inpatients admitted to Århus university Hospital , Risskov or outpatients from the psychiatry district centres or practising specialist in the area.
* Moderate - severe depression according to ICD-10/ DSM-IVR
* Age 18-80 years
* Total Hamilton score ( 17-items) of ≥ 18 or subscale score ≥ 9
* Right handed

Exclusion Criteria

* Organic brain disease
* Epilepsy in growing age
* Metallic objects as the result of a chest or Brain surgery
* Cardiac pacemakers
* Somatic diseases associated with brain dysfunction
* Pregnancy
* Suicide risk of severe degree
* Severe agitation or delirium
* Alcohol and drug dependency
* Ongoing Electroconvulsive treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Poul Erik B Hansen, consultant

Role: PRINCIPAL_INVESTIGATOR

University Hospital og Aarhus, Denmark

Locations

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University Hospital of Aarhus, Risskov

Aarhus, Risskov, Denmark

Site Status

Countries

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Denmark

References

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Klein E, Kreinin I, Chistyakov A, Koren D, Mecz L, Marmur S, Ben-Shachar D, Feinsod M. Therapeutic efficacy of right prefrontal slow repetitive transcranial magnetic stimulation in major depression: a double-blind controlled study. Arch Gen Psychiatry. 1999 Apr;56(4):315-20. doi: 10.1001/archpsyc.56.4.315.

Reference Type BACKGROUND
PMID: 10197825 (View on PubMed)

Other Identifiers

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M-20070144

Identifier Type: -

Identifier Source: org_study_id

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