- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01977521
Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations (tDCS)
May 2, 2017 updated by: Iris Sommer
Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations A Sham-controlled Trial
The present study aims to examine the efficacy of transcranial direct current stimulation on the severity of auditory hallucinations.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Iris Sommer, PhD
- Phone Number: +31887556365
- Email: I.Sommer@umcutrecht.nl
Study Contact Backup
- Name: Sanne Koops, MSc
- Phone Number: +31887558672
- Email: S.Koops@umcutrecht.nl
Study Locations
-
-
-
Utrecht, Netherlands, 3584 CX
- Recruiting
- UMC
-
Contact:
- Sanne Koops, MSc
- Phone Number: +31887558672
- Email: S.Koops@umcutrecht.nl
-
Contact:
- Iris Sommer, PhD
- Phone Number: +31887556365
-
Principal Investigator:
- Iris Sommer, PhD
-
Sub-Investigator:
- Sanne Koops, MSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
transcranial direct current stimulation (2mA)
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire
Time Frame: 4 years
|
4 years
|
Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS)
Time Frame: 4 years
|
4 years
|
Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS)
Time Frame: 4 years
|
4 years
|
Prior expectations regarding the efficacy of the treatment of the participants
Time Frame: 4 years
|
4 years
|
Strength of the motor threshold as assessed using TMS
Time Frame: 4 years
|
4 years
|
The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire
Time Frame: 4 years
|
4 years
|
Interference score on the Stroop task
Time Frame: 4 years
|
4 years
|
Score on the Trailmaking test A and B
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Iris Sommer, PhD, UMC Utrecht
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
February 1, 2018
Study Completion (Anticipated)
February 1, 2018
Study Registration Dates
First Submitted
October 30, 2013
First Submitted That Met QC Criteria
October 30, 2013
First Posted (Estimate)
November 6, 2013
Study Record Updates
Last Update Posted (Actual)
May 3, 2017
Last Update Submitted That Met QC Criteria
May 2, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Schizophrenia Spectrum and Other Psychotic Disorders
- Otorhinolaryngologic Diseases
- Ear Diseases
- Trauma and Stressor Related Disorders
- Sensation Disorders
- Perceptual Disorders
- Stress Disorders, Traumatic
- Personality Disorders
- Disease
- Psychotic Disorders
- Stress Disorders, Post-Traumatic
- Mental Disorders
- Mood Disorders
- Hallucinations
- Hearing Disorders
Other Study ID Numbers
- tDCS_UMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Personality Disorders
-
Icahn School of Medicine at Mount SinaiCompletedBorderline Personality Disorders | Avoidant Personality DisordersUnited States
-
University Hospital, Basel, SwitzerlandLeading House for the Latin American Region (Seed Money Grant SMG 1730)WithdrawnBorderline Personality Disorder (BPD)
-
University of Colorado, DenverCompleted
-
Health Service Executive, IrelandCompletedPersonality Disorder, Borderline
-
NHS Greater Glasgow and ClydeUnknownBorderline Personality Disorder (BPD) | Antisocial Personality Disorder (ASPD)United Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingBorderline Personality Disorders | BPDSpain
-
Hospital Universitari Vall d'Hebron Research InstituteUnknownBorderline Personality Disorder.Spain
-
Universitat Jaume IHospital de la RiberaNot yet recruitingBorderline Personality Disorder (BPD)Spain
-
University of OldenburgProf. René Hurlemann; Jella Voelter, M.Sc.RecruitingBorderline Personality Disorder (BPD)Germany
-
Universidad Nacional Autonoma de MexicoCompletedPsychopathic Personality TraitMexico
Clinical Trials on Eldith DC Stimulator stimulation
-
Institut National de la Santé Et de la Recherche...Completed
-
Pusan National UniversityUnknown
-
Ludwig-Maximilians - University of MunichCompletedTherapy Resistant Major DepressionGermany
-
The University of New South WalesCompleted
-
The University of New South WalesCompletedMajor DepressionAustralia
-
The University of New South WalesCompleted
-
Beth Israel Deaconess Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Boston...Completed
-
Ludwig-Maximilians - University of MunichCompleted
-
The University of New South WalesCompletedBipolar Disorder | Depressive Disorder, MajorAustralia
-
Hospices Civils de LyonCompleted