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van CCT (UK)

Treatment of hallucinated "voices" with repetitive transcranial magnetic stimulation: Mechanism and efficacy.

- candidate number5748
- NTR NumberNTR1813
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mei-2009
- Secondary IDs2006/052 MEC UMCG
- Public TitleTreatment of hallucinated "voices" with repetitive transcranial magnetic stimulation: Mechanism and efficacy.
- Scientific TitleMechanism and efficacy of low frequency rTMS treatment in schizophrenic patients with auditory hallucinations: An fMRI study.
- hypothesisLow frequency rTMS has inhibitory effects on underlying cortical tissue, which suggests a therapeutic value against the pathological overactivation of speech cortex in schizophrenia patients with voice hallucinations. NeuroImaging studies point to involvement of bilateral temporal cortices in the genesis of AVH. The study will assess whether bilateral rTMS produces additional beneficial effects in terms of symtpom improvement, particulary in the emotional salience of and reactivity to the auditory-verbal hallucinations.
- Healt Condition(s) or Problem(s) studiedSchizophrenia, Auditory-verbal hallucinations
- Inclusion criteriaInpatients as well as outpatients can participate. All patients should meet the diagnostic criteria for schizophrenia or schizoaffective disorder, and should report fairly frequent auditory hallucinations (at least daily). This inclusion information will be based on the patientís medical file and a structured psychiatric interview (Schedules for clinical Assessments in Neuropsychiatry, SCAN) conducted at intake). Patients should also meet the criteria for medication resistance, defined as persistent auditory hallucinations occurring in face of at least two adequate trials of antipsychotic medication. Patients stay on their regular medication for the complete duration of the study.
- Exclusion criteriaExclusion criteria include rTMS contraindications (e.g. a personal or family history of epileptic seizures, past neurosurgical procedures, intracerebral or pacemaker implants, inner ear prosthesis or other metal prosthetics/implants), neurological disorders, history of significant head trauma, severe behavioral disorders, and current substance abuse. For safety reasons we will also exclude female participants who may be pregnant. Subjects must show decision competence. Patients admitted under BOPZ regulation are not allowed to participate. Furthermore, the ability to give informed consent will be assessed by the patientís psychiatrist or clinical psychologist. Only subjects who are fully capable of making their own decision regarding participation in the research will be included. Patients with an active psychosis cannot participate due to a lack of concentration and understanding necessary for completion of the procedure.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2006
- planned closingdate
- Target number of participants48
- Interventions1. 1 Hz repetitive transcranial magnetic stimulation;
2. 12 sessions of 20 minutes, over 6 consecutive working days;
3. Stimulation intensity set at 90% of resting motor threshold.
- Primary outcomeAuditory Hallucination Rating Scale (AHRS).
- Secondary outcome1. Positive and Negative Affect Scale (PANAS);
2. Beliefs about Voices Questionnaire (BAVQ);
3. Positive and Negative Syndrome Scale (PANSS);
4. Hallucination item P3.
- Timepoints1. Timepoint 1: before start of rTMS;
2. Timepoint 2: after 3 days of rTMS treatment;
3. Timepoint 3: after 6 days of rTMS treatment;
4. Follow up 1: 1 week post treatment;
5. Follow up 2: 1 month post treatment;
6. Follow up 3: 3 months post treatment, and de-blinding of treatment conditions.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator University of Groningen & University Medical Center Groningen, Department of Neuroscience
- Funding
(Source(s) of Monetary or Material Support)
University of Groningen
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD14-mei-2009 - 30-sep-2009

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