Clinical trial NCT01977521: Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations
Official title: Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations A Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotic Disorders
Mood Disorders
Personality Disorders
Stress Disorders, Post-Traumatic
Hearing Disorders
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to examine the efficacy of transcranial direct current stimulation on the severity of auditory hallucinations.

Detailed description: Rationale: 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.

Eligibility criteria: Inclusion Criteria:

* Age over 18.
* Frequent auditory hallucinations (at least 5 times a week).
* 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 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, or a history of seizures in first-degree relatives.
* 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

Primary outcomes:
measure: Total score of the Auditory Hallucination Rating Scale (AHRS) questionnaire
timeFrame: 4 years
Secondary outcomes:
measure: Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire
timeFrame: 4 years
measure: Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS)
timeFrame: 4 years
measure: Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS)
timeFrame: 4 years
measure: Prior expectations regarding the efficacy of the treatment of the participants
timeFrame: 4 years
measure: Strength of the motor threshold as assessed using TMS
timeFrame: 4 years
measure: The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire
timeFrame: 4 years
measure: Interference score on the Stroop task
timeFrame: 4 years
measure: Score on the Trailmaking test A and B
timeFrame: 4 years
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC
Study officials:
affiliation: UMC Utrecht
name: Iris Sommer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koops S, Blom JD, Bouachmir O, Slot MI, Neggers B, Sommer IE. Treating auditory hallucinations with transcranial direct current stimulation in a double-blind, randomized trial. Schizophr Res. 2018 Nov;201:329-336. doi: 10.1016/j.schres.2018.06.010. Epub 2018 Jun 20.