Psychotic DisorderstDCSNCT01977521
Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations
A study testing Eldith DC Stimulator stimulation in people with Psychotic Disorders and Mood Disorders, run by Iris Sommer at 1 site in Netherlands.
Trial summary
The present study aims to examine the efficacy of transcranial direct current stimulation on the severity of auditory hallucinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Mood Disorders, Personality Disorders
- What is being tested?
- Eldith DC Stimulator stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
UMC
Utrecht, 3584 CX
Sanne Koops, MSc, +31887558672, S.Koops@umcutrecht.nl
Iris Sommer, PhD, +31887556365
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychotic Disorders, Mood Disorders, Personality Disorders, Stress Disorders, Post-Traumatic, Hearing Disorders
- Being tested
- Eldith DC Stimulator stimulation, Eldith DC Stimulator sham stimulation
- Medical subject headings
- Psychotic Disorders, Mood Disorders, Personality Disorders, Stress Disorders, Post-Traumatic, Hearing Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eldith DC Stimulator stimulationDevice
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.
Eldith DC Stimulator sham stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | transcranial direct current stimulation (2mA) Receives: Device: Eldith DC Stimulator stimulation |
| Sham | Sham comparator | Sham stimulation Receives: Device: Eldith DC Stimulator sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 years
Secondary outcomes (8)
Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire
Measured: 4 years
Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS)
Measured: 4 years
Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS)
Measured: 4 years
Prior expectations regarding the efficacy of the treatment of the participants
Measured: 4 years
Strength of the motor threshold as assessed using TMS
Measured: 4 years
The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire
Measured: 4 years
Interference score on the Stroop task
Measured: 4 years
Score on the Trailmaking test A and B
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iris Sommer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Iris Sommer, UMC Utrecht
- Investigators
- Iris Sommer, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977521
- Sponsor's protocol ID
- tDCS_UMC
- Acronym
- tDCS
- Status last verified
- May 2017
- First submitted
- 30 Oct 2013
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29934249
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation as Treatment for Auditory Hallucinations A Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT01977521
- Acronym / sponsor ID
- tDCS / tDCS_UMC
- Conditions
- Psychotic Disorders, Mood Disorders, Personality Disorders, Stress Disorders, Post-Traumatic, Hearing Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Iris SommerUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Eldith DC Stimulator stimulationtranscranial direct current stimulation (2mA) |
| Sham | Sham comparator | Device: Eldith DC Stimulator sham stimulationSham stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eldith DC Stimulator stimulationThe 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. | Device | Treatment |
| Eldith DC Stimulator sham stimulationThe 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. | Device | Sham |
Primary outcome
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)
8 secondary outcomes
Changes in severity of hallucinations as assessed by the hallucination change scale (HCS)questionnaire
Time frame: 4 years
Changes of positive, negative and disorganized symptomatology as assessed by the positive and negative syndrome scale (PANSS)
Time frame: 4 years
Severity of psychotic symptoms will be measured by the questionnaire for psychotic symptoms (QPS)
Time frame: 4 years
Prior expectations regarding the efficacy of the treatment of the participants
Time frame: 4 years
Strength of the motor threshold as assessed using TMS
Time frame: 4 years
The presence and severity of side-effects will be monitored using the tDCS adverse effects questionnaire
Time frame: 4 years
Interference score on the Stroop task
Time frame: 4 years
Score on the Trailmaking test A and B
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Derived from this study: PubMed 29934249Koops 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iris Sommer, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eldith DC Stimulator stimulation in people with Psychotic Disorders and Mood Disorders, run by Iris Sommer at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iris Sommer, PhD (+31887556365, I.Sommer@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score of the Auditory Hallucination Rating Scale (AHRS) questionnaire (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01977521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017; AzTrials last refreshed its copy on 1 Nov 2026.