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The Antidepressant Efficacy of Low Frequency rTMS as add-on

The Antidepressive Effect of Low Frequency Right Prefrontal Repetitive Transcranial Magnetic Stimulation as add-on to Antidepressant Drug Treatment. A Blinded, Placebo Controlled Randomised Study.

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02966106
Enrollment
0
Registered
2016-11-17
Start date
2016-12-31
Completion date
2017-12-31
Last updated
2017-11-29

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

Conditions

Depression

Brief summary

rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the brain through a time varying magnetic field. ). Research on rTMS reports of minimal side effects of the method . The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex . Fewer studies have used right prefrontal, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation .Both stimulus models has been shown to have statistically significant antidepressant effect and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex i associated with an antidepressant effect at the same level as the high frequency model. Therefore the investigators want to examine the antidepressant effect of a specific rTMS low frequency model in a clinical setting using a placebo controlled, randomized double blind design.

Detailed description

rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive 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). To some extent, this differential effect of different frequencies is reflected in human studies (REF). The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex , which has been approved by the USA FDA (1) and later in EU for the treatment of depression. Fewer studies have used right prefrontal, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation . In addition low frequency rTMS is generally less time-consuming. Both stimulus models has been shown to have a modest, statistically significant antidepressant effect and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex i associated with an antidepressant effect at the same level as the high frequency model. The issue indicates that low frequency due to the more advantagous side effect profile should be the stimulus model of choice in a clinical setting. Therefore the investigators want to examine the antidepressant effect of a specific rTMS low frequency model in a clinical setting using a placebo controlled, randomized double blind design.

Interventions

DEVICERight prefrontal low frequency rTMS

A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval

Right prefrontal rTMS sham treatment. A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

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

Inclusion criteria

1. Out-patients referred to Aarhus University Hospital, Risskov 2. Moderate-severe uni- and bipolar depression according to ICD-10 3. Age 18-80 years

Exclusion criteria

1. Organic brain disease. 2. Epileptic seizure \< 2 years 3. Patients with implanted metal parts in the brain or chest 4. Patients with pacemaker 5. Medical diseases with cerebral impact 6. Serious suicidal danger

Design outcomes

Primary

MeasureTime frameDescription
remission8 weeksthe number of patients obtaining a Hamilton-17 item total score of \< 8

Secondary

MeasureTime frameDescription
Response8 weeksthe number of patients obtaining a reduction in the 17-item score on the Hamilton scale for depression of \>= 50%
Cognitive function8 weeksPsychological testing of cognitive functions

Outcome results

None listed

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