Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations (tDCS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
Iris Sommer, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01977521
First received: October 30, 2013
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Psychotic Disorders
Mood Disorders
Personality Disorders
Stress Disorders, Post-Traumatic
Hearing Disorders
Device: Eldith DC Stimulator stimulation
Device: Eldith DC Stimulator sham stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations A Sham-controlled Trial

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Total score of the Auditory Hallucination Rating Scale (AHRS) questionnaire [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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:
  • Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Prior expectations regarding the efficacy of the treatment of the participants [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Strength of the motor threshold as assessed using TMS [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 62
Study Start Date: April 2014
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
transcranial direct current stimulation (2mA)
Device: Eldith DC Stimulator stimulation
The anodal electrode will be placed with the middle of the electrode over a point midway between F3 and FP1 (left prefrontal cortex: dorsolateral prefrontal cortex and the cathodal electrode located over a point midway between T3 and P3 (left temporo-parietal junction). Stimulation will consist of 2 mA for 20 minutes per session.
Sham Comparator: Sham
Sham stimulation
Device: Eldith DC Stimulator sham stimulation
The anodal electrode will be placed with the middle of the electrode over a point midway between F3 and FP1 (left prefrontal cortex: dorsolateral prefrontal cortex and the cathodal electrode located over a point midway between T3 and P3 (left temporo-parietal junction). In the sham condition, after 40 seconds of real stimulation (2 mA), only a small current pulse will occur every 550 msec (110 mA over 15 msec) through the remainder of the 20-minute period.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • In female patients, there should be no possibility for pregnancy as determined with a pregnancy test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977521

Contacts
Contact: Iris Sommer, PhD +31887556365 I.Sommer@umcutrecht.nl
Contact: Sanne Koops, MSc +31887558672 S.Koops@umcutrecht.nl

Locations
Netherlands
UMC Not yet recruiting
Utrecht, Netherlands, 3584 CX
Contact: Sanne Koops, MSc    +31887558672    S.Koops@umcutrecht.nl   
Contact: Iris Sommer, PhD    +31887556365      
Principal Investigator: Iris Sommer, PhD         
Sub-Investigator: Sanne Koops, MSc         
Sponsors and Collaborators
Iris Sommer
Investigators
Principal Investigator: Iris Sommer, PhD UMC Utrecht
  More Information

No publications provided

Responsible Party: Iris Sommer, Professor, Psychiatrist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01977521     History of Changes
Other Study ID Numbers: tDCS_UMC
Study First Received: October 30, 2013
Last Updated: February 24, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Hearing Disorders
Disease
Stress Disorders, Traumatic
Mood Disorders
Personality Disorders
Psychotic Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Hallucinations
Pathologic Processes
Anxiety Disorders
Schizophrenia and Disorders with Psychotic Features
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders

ClinicalTrials.gov processed this record on September 18, 2014