|- candidate number||3209|
|- NTR Number||NTR1279|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-apr-2008|
|- Secondary IDs||TMSDEP18061975 |
|- Public Title||Transcranial magnetic stimulation to the right parietal cortex in the treatment of depression.|
|- Scientific Title||Therapeutic effects of 2 Hz repetitive transcranial magnetic stimulation to the right parietal cortex in depression.|
|- hypothesis||Ten consecutive sessions of 2 Hz TMS (inter-pulse interval: 1 sec) at 90% MT to the right parietal cortex (2400 pulses p/session) will have antidepressant effects.|
|- Healt Condition(s) or Problem(s) studied||Depression, Transcranial magnetic stimulation (TMS)|
|- Inclusion criteria||1. Primary diagnosis of depressive disorder according to the DSM-IV (APA 2000); |
2. => 15 score on the Hamilton Rating Scale for Depression (HAM-D).
|- Exclusion criteria||1. History of seizures; |
2. Neurological conditions;
3. Metal objects in or around the body that cannot be removed (i.e., cochlear implant, surgical clips, piercing, cardiac pacemaker);
4. Heart disease;
6. Drug and alcohol abuse.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2004|
|- planned closingdate||31-dec-2007|
|- Target number of participants||34|
|- Interventions||Transcranial magnetic stimulation: 2 Hz TMS (inter-pulse interval: 1 sec) at 90% MT to the right parietal cortex (2400 pulses p/session). 10 sessions in total.|
|- Primary outcome||The percentage change from baseline on the HAM-D scores|
|- Secondary outcome||N/A|
|- Timepoints||t=1: week 0 - baseline; |
t=2: week 2 - endpoint.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD PhD G.F. Koerselman|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD G.F. Koerselman|
|- Sponsor/Initiator ||St. Lucas Andreas Hospital, Department of Psychiatry|
(Source(s) of Monetary or Material Support)
|Netherlands Organization for Scientific Research (NWO)|
|- Publications||In preparation|
|- Brief summary||Background: |
The aim of the current treatment study was to evaluate the therapeutic effects of transcranial magnetic stimulation (TMS) over the right parietal cortex in depression.
In a double-blind sham-controlled design ten consecutive sessions of 2 Hz TMS (inter-pulse interval: 1 sec) at 90% MT to the right parietal cortex (2400 pulses p/session) were applied to thirty-four patients with the primary diagnosis of DSM-IV depression and a > 15 score on the 17-item Hamilton Rating Scale for Depression (HAM-D). The primary outcome measures were the percentage change from baseline on the 17-item HAM-D scores after ten sessions, and the percentage clinical (> 50% reduction in HAM-D score) and partial clinical responders (> 30% reduction in HAM-D score).
The reduction of HAM-D scores in the real TMS treatment (meanreal ± SD, -19.9 ± 32.5%) was not statistically different from the sham TMS treatment (meansham ± SD, -5.6 ± 28.4%), and the number of clinical responders did not differ between treatments. However, a significant greater number of partial clinical responders was observed in the real (43.8%) as compared to the sham TMS treatment (6.3%).
The current study provides the first evidence showing that 2 Hz TMS over the right parietal cortex may have antidepressant properties and warrants further research.
|- Main changes (audit trail)|
|- RECORD||17-apr-2008 - 18-jan-2010|