Transcranial Direct Current Stimulation as treatment for Auditory Hallucinations. A sham-controlled trial

Completed

Conditions: psychiatrische stoornissen
auditory hallucinations
hearing of voices

Registration Number: NL-OMON45026

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 102

Inclusion Criteria

- Diagnosis of schizophrenia-spectrum disorder, affective disorder, personality disorder, post-traumatic stress disorder or hearing disorder.
- Age over 18
- Frequent auditory hallucinations (at least 5 times a week as indicated by the screening form).
- Patients are on a stable dose of antipsychotic medication (which can also be zero) for at least 2 weeks
- Mentally competent for informed consent.
- Provided written informed consent.

Exclusion Criteria

- Metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing)
- History of seizures
- History of eye trauma with a metal object or professional metal workers
- History of brain surgery, brain infarction, head trauma, cerebrovascular accident, broken skull, brain tumour, heart disease, cardiac pacemaker.
- Skin disease on the scalp on the position of the tDCS electrodes
- Coercive treatment based on a judicial ruling
- Pregnancy in female patients. A pregnancy test will be used in cases of doubt, e.g. females of childbearing age who are sexually active but do not use any form of contraceptives.
- Participation in TMS research in the previous 6 months
- Mentally incompetent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The severity of the AH as measured with the Auditory Hallucination Rating Scale<br /><br>(AHRS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are: the severity of AH as measured with the hallucination<br /><br>change scale (HCS), schizophrenia symptom severity as measured by the positive<br /><br>and negative syndrome scale (PANSS), severity of psychotic symptoms as measured<br /><br>by the questionnaire of psychotic symptoms (QPS), prior expectations regarding<br /><br>the efficacy of treatment, presence and severity of side-effects of tDCS, and<br /><br>the motor threshold as determined by transcranial magnetic stimulation (TMS).<br /><br>Cognitive functioning as measured by the Stroop test and the Trail-Making Test.<br /><br>The effect of age on the decrease of severity AH as measured with the AHRS.</p><br>