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A double blind placebo controlled trial comparing the effect of repetitive Transcranial Magnetic Stimulation (rTMS) of two treatment strategies for Auditory Verbal Hallucinations (AVH).


- candidate number6470
- NTR NumberNTR2012
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-sep-2009
- Secondary IDs05/163-O METC UMCU
- Public TitleA double blind placebo controlled trial comparing the effect of repetitive Transcranial Magnetic Stimulation (rTMS) of two treatment strategies for Auditory Verbal Hallucinations (AVH).
- Scientific TitleIs fMRI guided rTMS superior to rTMS directed to the left temporoparietal (TP) and sham in the treatent of AVH?
- ACRONYMN/A
- hypothesisWe expect that both treatment conditions are better than sham and that fMRI guided rTMS is superior to rTMS directed to the left TP.
- Healt Condition(s) or Problem(s) studiedSchizophrenia, Repetitive transcranial magnetic stimulation (rTMS) , Auditory-verbal hallucinations
- Inclusion criteria1. Medication resistant AVH;
2. AVH more than once per hour;
3. Written informed consent.
- Exclusion criteria1. Epilepsy;
2. Pregnancy;
3. Drug/alcohol abuse;
4. Daily use of benzodiazepines;
5. Use of anti-epileptic agents;
6. Claustrophobia;
7. Metal in or around the body that cannot be removed.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2008
- planned closingdate31-okt-2011
- Target number of participants100
- InterventionsrTMS treatment 15 treatment sessions of 20 minutes in a frequency of 1 hertz and an individual motor threshold of 90%.
- Primary outcomeAuditory Hallucination Rating Scale.
- Secondary outcome1. Positive items of the Positive And Negative Symptoms Scale (PANSS);
2. Psychotic symptom rating scales (PSYRATS).
- Timepoints2008-2009 inclusion and participation of patients.
2010-2011 data analysis.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES C.W. Slotema
- CONTACT for SCIENTIFIC QUERIES C.W. Slotema
- Sponsor/Initiator Parnassia, psycho-medische zorg, University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Stichting tot Steun (VCVGZ)
- PublicationsN/A
- Brief summaryPatients with frequent, treatment resistant AVH are randomized for three treatment conditons: 1. rTMS directed to the left temporoparietal area, 2. rTMS directed to the brain area with maximum acitivity during the experience of AVH and 3. sham treatment. Assessments are held at baseline, at each end of the week of treatment, and one, two and three months after the treatment.
- Main changes (audit trail)
- RECORD14-sep-2009 - 4-nov-2009


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