Experimental treatment of depression with MRI-guided cerebellar transcranial magnetic stimulation: A pilot study

Withdrawn

Conditions: depressie
unipolaire stoornis

Registration Number: NL-OMON30011

Lead Sponsor: niversiteit Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Particpants that fulfill the DSM criteria for depression during screening and at treatment session 1.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proposed treatment protocol may provide the first steps towards developing<br /><br>an alternative therapy for patients who do not respond to antidepressant<br /><br>medication. For this group the potential effects on quality of life are<br /><br>expected to be high, since cerebellar rTMS may decrease depression severity<br /><br>subsequently reducing apathy and promote social functioning in these patients.<br /><br>The end-point of the primary outcome measures, the change in severity of<br /><br>depression will be compared to the placebo and TMS condition correcting for<br /><br>baseline value using co-variance analysis (ANCOVA) (Vickers & Altman, BMJ<br /><br>2001;323:1123-4). Level of significance will be set at p < 0.05 (two-tailed)<br /><br>throughout.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are the TMS induced changes in electric brain<br /><br>activity (EEG) and blood flow (ASL) at t=0 and t=15. A separate ANCOVA will<br /><br>performed for the EEG and ASL. Level of significance will be set at p < 0.05<br /><br>(two-tailed) throughout.</p><br>