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

The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham: A Clinical Controlled, Randomized, Blinded Study

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.

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder
• Intervention / Treatment: Procedure: right temporal low frequency (1 hz) rTMS; Procedure: Sham-rTMS

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Risskov
    • Aarhus, Risskov, Denmark, 8240
      • University hospital of Aarhus, Risskov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: right temporal low frequency (1 hz) rTMS; Right temporal low frequency (1 hz) rTMS.; Other Names: A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular coil is used.
Sham Comparator: 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.	Procedure: Sham-rTMS; The coil is angled 90 degrees away from the scalp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total 17-item score on the Hamilton scale for depression	semistructured interview scale.	4 weeks of treatment and 4 weeks of follow-up

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Poul Erik B Hansen, consultant, University Hospital og Aarhus, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: January 24, 2008
• First Submitted That Met QC Criteria: February 22, 2008
• First Posted (Estimate): February 25, 2008

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Depression; cognition; rTMS; saliva cortisol; sham; antidepressant effect; brain derived neurotropic factor
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: M-20070144