Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations
tDCS
1 other identifier
interventional
62
1 country
1
Brief Summary
The present study aims to examine the efficacy of transcranial direct current stimulation on the severity of auditory hallucinations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2013
CompletedFirst Posted
Study publicly available on registry
November 6, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMay 3, 2017
May 1, 2017
3.8 years
October 30, 2013
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Total score of the Auditory Hallucination Rating Scale (AHRS) questionnaire
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
Treatment
EXPERIMENTALtranscranial direct current stimulation (2mA)
Sham
SHAM COMPARATORSham stimulation
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Iris Sommerlead
Study Sites (1)
UMC
Utrecht, 3584 CX, Netherlands
Related Publications (1)
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.
PMID: 29934249DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iris Sommer, PhD
UMC Utrecht
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Psychiatrist
Study Record Dates
First Submitted
October 30, 2013
First Posted
November 6, 2013
Study Start
April 1, 2014
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
May 3, 2017
Record last verified: 2017-05