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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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00622947
Enrollment
10
Registered
2008-02-25
Start date
2008-02-29
Completion date
2010-02-28
Last updated
2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Keywords

Depression, antidepressant effect, rTMS, sham, cognition, saliva cortisol, brain derived neurotropic factor

Brief summary

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

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.

Interventions

PROCEDUREright temporal low frequency (1 hz) rTMS

Right temporal low frequency (1 hz) rTMS.

PROCEDURESham-rTMS

The coil is angled 90 degrees away from the scalp

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The total 17-item score on the Hamilton scale for depression4 weeks of treatment and 4 weeks of follow-upsemistructured interview scale.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026