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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45026
Enrollment
102
Registered
2014-01-24
Start date
2014-05-30
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychiatrische stoornissen auditory hallucinations hearing of voices

Interventions

The participant will receive either 10 tDCS treatments or 10 sham treatments, consisting of 2 mA tDCS or sham stimulation on 5 consecutive weekdays. The anode will be placed over the left dorsolater

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The severity of the AH as measured with the Auditory Hallucination Rating Scale (AHRS).

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)