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

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ClinicalTrials.gov Identifier: NCT01977521
Recruitment Status : Recruiting
First Posted : November 6, 2013
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Iris Sommer, UMC Utrecht

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

Condition or disease Intervention/treatment Phase
Psychotic Disorders Mood Disorders Personality Disorders Stress Disorders, Post-Traumatic Hearing Disorders Device: Eldith DC Stimulator stimulation Device: Eldith DC Stimulator sham stimulation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations A Sham-controlled Trial
Study Start Date : April 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Total score of the Auditory Hallucination Rating Scale (AHRS) questionnaire [ Time Frame: 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 :
  1. Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire [ Time Frame: 4 years ]
  2. Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS) [ Time Frame: 4 years ]
  3. Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS) [ Time Frame: 4 years ]
  4. Prior expectations regarding the efficacy of the treatment of the participants [ Time Frame: 4 years ]
  5. Strength of the motor threshold as assessed using TMS [ Time Frame: 4 years ]
  6. The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire [ Time Frame: 4 years ]
  7. Interference score on the Stroop task [ Time Frame: 4 years ]
  8. Score on the Trailmaking test A and B [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • Pregnancy in female patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977521


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

Locations
Netherlands
UMC 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

Responsible Party: Iris Sommer, Professor, Psychiatrist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01977521     History of Changes
Other Study ID Numbers: tDCS_UMC
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

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