Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations

NCT ID: NCT01977521

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Psychotic Disorders Mood Disorders Personality Disorders Stress Disorders, Post-Traumatic Hearing Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment

transcranial direct current stimulation (2mA)

Group Type EXPERIMENTAL

Eldith DC Stimulator stimulation

Intervention Type DEVICE

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

Sham stimulation

Group Type SHAM_COMPARATOR

Eldith DC Stimulator sham stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iris Sommer

OTHER

Sponsor Role lead

Responsible Party

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Iris Sommer

Professor, Psychiatrist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Iris Sommer, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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UMC

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Iris Sommer, PhD

Role: CONTACT

+31887556365

Sanne Koops, MSc

Role: CONTACT

+31887558672

Facility Contacts

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Sanne Koops, MSc

Role: primary

+31887558672

Iris Sommer, PhD

Role: backup

+31887556365

References

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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.

Reference Type DERIVED
PMID: 29934249 (View on PubMed)

Other Identifiers

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tDCS_UMC

Identifier Type: -

Identifier Source: org_study_id

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