depressie unipolaire stoornis
Conditions
Interventions
Repetitive transcranial magnetic stimulation will be applied to the midline
cerebellum. rTMS parameters: 80% motor threshold, 25 Hz, 10s on, 5s off for 20
minutes (i.e., 20,000 pulses per session).
Sponsors
Universiteit Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Particpants that fulfill the DSM criteria for depression during screening and at treatment session 1.
Exclusion criteria
Exclusion criteria: History of seizures, metal objects in or around the body that cannot be removed (i.e. cochlear implant, surgical clips, piercing, cardiac pacemaker), history of eye trauma with a metal object, professional metal workers, heart disease, alcohol abuse (cut-off: >3 drinks per day) and drug use. In female patients, there should be no possibility for pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proposed treatment protocol may provide the first steps towards developing an alternative therapy for patients who do not respond to antidepressant medication. For this group the potential effects on quality of life are expected to be high, since cerebellar rTMS may decrease depression severity subsequently reducing apathy and promote social functioning in these patients. The end-point of the primary outcome measures, the change in severity of depression will be compared to the placebo and TMS condition correcting for baseline value using co-variance analysis (ANCOVA) (Vickers & Altman, BMJ 2001;323:1123-4). Level of significance will be set at p | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are the TMS induced changes in electric brain activity (EEG) and blood flow (ASL) at t=0 and t=15. A separate ANCOVA will performed for the EEG and ASL. Level of significance will be set at p | — |
Countries
Netherlands
Outcome results
None listed