Ignite Creation Date:
2024-05-06 @ 12:50 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03868774
Status:
WITHDRAWN
Last Update Posted:
2019-08-19
First Post:
2019-03-07
Brief Title:
The Antidepressant Effect of Right Prefrontal Low Frequency rTMS in an Accelerated Treatment Model
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
The Antidepressant Effect of Right Prefrontal Low Frequency rTMS in an Accelerated Treatment Model rTMS An Open Controlled Randomized Study
Status:
WITHDRAWN
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of ressources
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Repetitive transcranial magnetic stimulation has appeared a new non-invasive antidepressant method which implies non-convulsive focal stimulation of the prefrontal cortex of the brain through a time varying magnetic field The method is associated with minimal side effects limited to local discomfort and especially no impact on cognitive function The method has been approved for the treatment of depression in Canada USA and a couple of European countries The department for Affective Disorders Aarhus University Hospital has used rTMS as add-on to conventional antidepressant treatment in the outpatient clinic since 2015 A single treatment course covers 20 sessions given on 20 consecutive days The demand for daily treatment and attendance for 20 days is resource demanding for both the patient and the clinic In consequence the investigators want to examine the antidepressant effect of an accelerated stimulus model comparing the outcome of the standard model 20 days with a treatment model covering the same number of stimuli given within one week
Detailed Description:
rTMS has appeared a potential new non-invasive antidepressant method which implies nonconvulsive focal stimulation of the brain through a time varying magnetic field RTMS is based on the principle of electromagnetism An electromagnetic coil placed on the scalp produces a time-varying magnetic field that penetrates the scalp and skull unattenuated and gives rise to a current in the proximity of the cerebral cortex as well as functionally connected parts of the brain Research on rTMS reports of minimal side effects of the method
Previous research indicates that the antidepressant effect of rTMS is associated with specific stimulation of the dorsolateral prefrontal cortex The stimulus frequency has shown to play a key role in the mechanisms of action of rTMS Previous animal studies have shown that low frequency rTMS is associated with long term inhibition of neuronal activity long term depression while high frequency stimulation is followed by prolonged activation long term potentiation The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex which has been approved by the USA and later in the European Union for the treatment of depression Fewer studies have used right prefrontal low frequency rTMS which has less side effects such as local discomfort and a lower risk of releasing epileptic seizures than high frequency stimulation Randomized controlled trials and meta-analysis have shown that both stimulus models have a clinically significant antidepressant effect at the same level as antidepressant drugs and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex is associated with an antidepressant effect at the same level as the high frequency model The issue indicates that low frequency due to the more advantageous side effect profile should be the stimulus model of choice in a clinical setting
The Department for Affective Disorders Aarhus University Hospital has taken part in rTMS research since 1999 and the outpatient clinic has used low frequency rTMS as add-on to conventional antidepressant treatment since 2015 A single treatment course covers 20 treatment sessions given on 20 consecutive days The demand for daily treatment and attendance in the outpatient clinic for 20 days is resource demanding both for the patient and the clinic In consequence the investigators want to examine the antidepressant effect of an accelerated stimulus model comparing the antidepressant efficacy of conventional treatment 20 days with a treatment model covering the same number of stimuli given within one weekThe study is lightening the significance of the association between the number of stimulus pulses the length of the total treatment period and the antidepressant effect Patients suffering for depression may benefit from the outcome of the study by obtaining an accelerated antidepressant effect from a less time consuming stimulus model The outcome of the study may be implemented in clinical practice from day one
Previous research indicates that the antidepressant effect of rTMS is associated with specific stimulation of the dorsolateral prefrontal cortex The stimulus frequency has shown to play a key role in the mechanisms of action of rTMS Previous animal studies have shown that low frequency rTMS is associated with long term inhibition of neuronal activity long term depression while high frequency stimulation is followed by prolonged activation long term potentiation The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex which has been approved by the USA and later in the European Union for the treatment of depression Fewer studies have used right prefrontal low frequency rTMS which has less side effects such as local discomfort and a lower risk of releasing epileptic seizures than high frequency stimulation Randomized controlled trials and meta-analysis have shown that both stimulus models have a clinically significant antidepressant effect at the same level as antidepressant drugs and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex is associated with an antidepressant effect at the same level as the high frequency model The issue indicates that low frequency due to the more advantageous side effect profile should be the stimulus model of choice in a clinical setting
The Department for Affective Disorders Aarhus University Hospital has taken part in rTMS research since 1999 and the outpatient clinic has used low frequency rTMS as add-on to conventional antidepressant treatment since 2015 A single treatment course covers 20 treatment sessions given on 20 consecutive days The demand for daily treatment and attendance in the outpatient clinic for 20 days is resource demanding both for the patient and the clinic In consequence the investigators want to examine the antidepressant effect of an accelerated stimulus model comparing the antidepressant efficacy of conventional treatment 20 days with a treatment model covering the same number of stimuli given within one weekThe study is lightening the significance of the association between the number of stimulus pulses the length of the total treatment period and the antidepressant effect Patients suffering for depression may benefit from the outcome of the study by obtaining an accelerated antidepressant effect from a less time consuming stimulus model The outcome of the study may be implemented in clinical practice from day one
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None