The present study aims to examine the efficacy of tDCS on the severity of AH.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychiatrische stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The severity of the AH as measured with the Auditory Hallucination Rating Scale
(AHRS).
Secondary outcome
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.
Background summary
Auditory hallucinations (AH) are a symptom of several psychiatric disorders,
such as schizophrenia. In the majority of patients, these AH respond well to
antipsychotic medication. Yet, a significant minority continues to experience
frequent AH despite optimal pharmacotherapy and AH severely decrease quality of
life in these patients. The number of alternative treatment options for this
medication resistant group is currently low and most of them focus on coping
with the hallucinations. Transcranial direct current stimulation (tDCS), in
contrast, is a safe, non-invasive technique that is able to directly influence
cortical excitability through the application of very low electric currents.
This technique has only a few transient side-effects and is cheap and portable.
To date, only one randomized controlled trial has been published, suggesting
high efficacy of tDCS for the treatment of medication-resistant AH in a
relatively small sample. We aim to replicate and extend these findings by
investigating the efficacy of this technique in a larger sample.
Study objective
The present study aims to examine the efficacy of tDCS on the severity of AH.
Study design
The objectives are tested in a randomized double blind sham-controlled trial.
Intervention
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 dorsolateral prefrontal cortex and the
cathode over the left temporo-parietal cortex.
Study burden and risks
Participation includes 8 visits to the UMC Utrecht with a total duration of
approximately 20 hours. In these visits the questionnaires and interviews as
described above will be conducted four times. The currently proposed tDCS
procedure and the motor threshold TMS paradigm do not carry any significant
risks. Safety guidelines as acknowledged by the International Federation of
Clinical Neurophysiology will be followed strictly. Potential side-effects of
tDCS and TMS are itching and tingling sensations, skin irritation and muscle
tension and headache. These are generally mild discomforts that respond
promptly to common analgesics. Volunteers can withdraw from the study at any
time. AH can have a severe impact on an individual*s quality of life and that
of his/her surroundings. The proposed technique may offer an alternative
therapy for patients who do not respond to antipsychotic medication. It is
therefore expected that effects on health and social functioning are high,
since a decrease in hallucination severity will decrease fear and social
isolation in these patients.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01977521 |
| CCMO | NL46513.041.13 |