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

Primary Purpose

Psychotic Disorders, Mood Disorders, Personality Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Eldith DC Stimulator stimulation
Eldith DC Stimulator sham stimulation
Sponsored by
Iris Sommer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Sham

Arm Description

transcranial direct current stimulation (2mA)

Sham stimulation

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire
Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS)
Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS)
Prior expectations regarding the efficacy of the treatment of the participants
Strength of the motor threshold as assessed using TMS
The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire
Interference score on the Stroop task
Score on the Trailmaking test A and B

Full Information

First Posted
October 30, 2013
Last Updated
May 2, 2017
Sponsor
Iris Sommer
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1. Study Identification

Unique Protocol Identification Number
NCT01977521
Brief Title
Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations
Acronym
tDCS
Official Title
Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations A Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Iris Sommer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Mood Disorders, Personality Disorders, Stress Disorders, Post-Traumatic, Hearing Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
transcranial direct current stimulation (2mA)
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham stimulation
Intervention Type
Device
Intervention Name(s)
Eldith DC Stimulator stimulation
Intervention Description
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
Intervention Name(s)
Eldith DC Stimulator sham stimulation
Intervention Description
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 Measure Information:
Title
Total score of the Auditory Hallucination Rating Scale (AHRS) questionnaire
Description
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)
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire
Time Frame
4 years
Title
Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS)
Time Frame
4 years
Title
Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS)
Time Frame
4 years
Title
Prior expectations regarding the efficacy of the treatment of the participants
Time Frame
4 years
Title
Strength of the motor threshold as assessed using TMS
Time Frame
4 years
Title
The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire
Time Frame
4 years
Title
Interference score on the Stroop task
Time Frame
4 years
Title
Score on the Trailmaking test A and B
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Sommer, PhD
Phone
+31887556365
Email
I.Sommer@umcutrecht.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Sanne Koops, MSc
Phone
+31887558672
Email
S.Koops@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Sommer, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanne Koops, MSc
Phone
+31887558672
Email
S.Koops@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Iris Sommer, PhD
Phone
+31887556365
First Name & Middle Initial & Last Name & Degree
Iris Sommer, PhD
First Name & Middle Initial & Last Name & Degree
Sanne Koops, MSc

12. IPD Sharing Statement

Citations:
PubMed Identifier
29934249
Citation
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.
Results Reference
derived

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Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations

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