Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations

Not Applicable

• Conditions: Hearing Disorders; Personality Disorders; Stress Disorders, Post-Traumatic; Psychotic Disorders; Mood Disorders
• Interventions: Device: Eldith DC Stimulator stimulation; Device: Eldith DC Stimulator sham stimulation

• Registration Number: NCT01977521
• Lead Sponsor: Iris Sommer

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.

Study Timeline

• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Study Start: 2014-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Eldith DC Stimulator stimulation	transcranial direct current stimulation (2mA)
Sham	Eldith DC Stimulator sham stimulation	Sham stimulation

Primary Outcome Measures

Name	Time	Method
Total score of the Auditory Hallucination Rating Scale (AHRS) questionnaire	4 years	The primary outcome is the change in the severity of the hallucinations before and after the treatment, as experienced by the participant, measured with the Auditory Hallucination Rating Scale (AHRS)

Secondary Outcome Measures

Name	Time	Method
The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire	4 years
Interference score on the Stroop task	4 years
Score on the Trailmaking test A and B	4 years
Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire	4 years
Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS)	4 years
Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS)	4 years
Prior expectations regarding the efficacy of the treatment of the participants	4 years
Strength of the motor threshold as assessed using TMS	4 years

Trial Locations

Locations (1)

UMC; 🇳🇱 Utrecht, Netherlands