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

I

Iris Sommer

Status

Unknown

Conditions

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

Treatments

Device: Eldith DC Stimulator sham stimulation
Device: Eldith DC Stimulator stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01977521
tDCS_UMC

Details and patient eligibility

About

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

Full 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.

Enrollment

62 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

62 participants in 2 patient groups

Treatment
Experimental group
Description:
transcranial direct current stimulation (2mA)
Treatment:
Device: Eldith DC Stimulator stimulation
Sham
Sham Comparator group
Description:
Sham stimulation
Treatment:
Device: Eldith DC Stimulator sham stimulation

Trial contacts and locations

1

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Central trial contact

Sanne Koops, MSc; Iris Sommer, PhD

Data sourced from clinicaltrials.gov

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