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Auditory HallucinationtDCSNCT03485131

Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations

A study testing Transcranial direct-current stimulation (tDCS) in people with Auditory Hallucination and Schizophrenia, run by Manhattan Psychiatric Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a 4 week therapeutic pilot study with a 4 week follow-up period involving inpatients with treatment resistant DSM-IV schizophrenia or schizoaffective disorder diagnosis. Each eligible subject will receive either 20 minutes of active tDCS (transcranial direct-current stimulation) or sham stimulation twice a day… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Auditory Hallucination, Schizophrenia
What is being tested?
Transcranial direct-current stimulation (tDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteUnited States
Study dates
Apr 2014to Mar 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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inpatient adults (age 18-65 years) who meet diagnostic criteria for schizophrenia or schizoaffective disorder (using the Structured Clinical Interview for DSM)
  • Auditory hallucinations without remission over 5 years (remission is defined as a period of 4 weeks without hallucinations) as documented in the patients' medical record
  • Failure to respond to two previous adequate antipsychotic trials with adequate duration and adequate dosage
  • Screening PANSS total rating of > 70
  • PANSS hallucinatory behavior item > 4
  • Capacity and willingness to sign informed consent
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  • On a stable antipsychotic regimen 4 weeks prior to screening and for the duration of the trial
  • Normal hearing
  • If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an interuterine device (IUD) which was implanted at least 2 months prior to screening, or "double-barrier" contraception
  • Willing to wear the tDCS device.

Who cannot join

  • Prior history of seizure, other than that induced by Electro Convulsive Therapy
  • Family history of seizures
  • Significant unstable medical condition
  • Pregnancy or women of childbearing capacity not using a medically accepted form of contraception when engaged in sexual intercourse
  • Inability to provide informed consent
  • Actively suicidal and or showing violent behavior
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  • Significant organic brain pathology by history and neurological examination, inclusive of history of head trauma, loss of consciousness for more than 5 minutes; intracranial metal implants, known structural brain lesion, devices that may be affected by transcranial Direct Current Stimulation (tDCS) (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
  • Active substance abuse
  • Increased intracranial pressure, unstable cardiovascular disease, sleep apnea
  • Individuals with a clinically defined neurological disorder
  • Frequent and persistent migraines
  • History of adverse reaction to neurostimulation or open skin wounds that would preclude safe placement of tDCS electrodes
  • Current use of medications known to lower seizure threshold (serotonergic or tricyclic antidepressants)
  • If pregnant or breast feeding at the time of screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Manhattan Psychiatric Center

    New York, New York, 10035

Other trials in United States

About this study

Official title: Transcranial Direct-current Stimulation (tDCS) in Treatment Refractory Auditory Hallucinations: A Pilot Study

This is a 4 week therapeutic pilot study with a 4 week follow-up period involving inpatients with treatment resistant DSM-IV schizophrenia or schizoaffective disorder diagnosis. Each eligible subject will receive either 20 minutes of active tDCS (transcranial direct-current stimulation) or sham stimulation twice a day on 5 consecutive weekdays for 4 weeks with a 4 week follow-up period.

Read the detailed description

The aim in this study is to conduct a pilot study on the efficacy of tDCS by assessing its efficacy in treatment refractory auditory verbal hallucinations in inpatients with chronic schizophrenia. Based on and expanding the findings by Brunelin et al. the hypothesis is that tDCS treatment with the cathode on the left temporal-parietal junction and the anode on the left dorsolateral prefrontal cortex can reduce the severity of auditory verbal hallucinations in patients with treatment refractory schizophrenia. The impact of tDCS on other schizophrenia symptoms in secondary exploratory outcome analyses together with the examination of the durability of an ameliorating effect will also be investigated.

Being tested
Transcranial direct-current stimulation (tDCS), Placebo
Medical subject headings
Hallucinations, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial direct-current stimulation (tDCS)Device

    Also called Active Transcranial direct-current stimulation (tDCS)'

    Stimulation sessions will be conducted twice a day on 5 consecutive weekdays. The twice daily sessions will be separated by at least 3 hours (one in the morning and the other one in the PM). The duration of treatment will be 4 weeks

  • PlaceboDevice

    Also called Sham Transcranial direct-current stimulation (tDCS)

    Placebo/sham stimulation: After 40 seconds of real stimulation of 2 mAmp to simulate the tDCS induced skin sensation, only a small current pulse is delivered every 550 msec (110 mAmp over 15 msec) through the remainder of the 20-minute period

Study groups in NCT03485131
Study groupRoleWhat they receive
Transcranial direct-current stimulationExperimentalIntervention of 2 mAmp Transcranial direct-current stimulation treatments given twice daily for 20 min each per day for 4 weeks on consecutive weekdays. Twice-daily sessions were separated by at least 3 hours (one in the AM and the other one in the PM)
Receives: Device: Transcranial direct-current stimulation (tDCS)
Sham tDCSSham comparatorIntervention of placebo stimulation with ranscranial direct-current stimulation(sham tDCS), the stimulation parameters were displayed, but after 40 seconds of real stimulation of 2 mAmp to simulate the tDCS induced skin sensation, only a small current pulse was delivered every 550 msec (110 mAmp over 15 msec) through the remainder of the 20-minute period
Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction on the severity of auditory verbal hallucinations

    Reduction of Auditory Hallucinations Rating Scale (AHRS (12) items)

    Measured: 8 weeks

Secondary outcomes (3)

  1. Impact of tDCS on other schizophrenia symptoms

    Reduction of scores in Positive and Negative Symptom Scale

    Measured: 8 weeks

  2. Impact of tDCS on Clinical Global Impression

    Global Severity of Illness measure

    Measured: 8 weeks

  3. Impact of tDCS on MATRICS

    MATRICS: Comprehensive assessment of cognitive functions

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2018
  2. Study startApr 2014
  3. Primary completionJul 2017
  4. Study completionMar 2018

Resources

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
Model description
Two group randomized, parallel design
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03485131
Sponsor's protocol ID
1409
Acronym
tDCS
Status last verified
Mar 2018
First submitted
1 Mar 2016
Last updated
4 Apr 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Nitsche MA, Boggio PS, Fregni F, Pascual-Leone A. Treatment of depression with transcranial direct current stimulation (tDCS): a review. Exp Neurol. 2009 Sep;219(1):14-9. doi: 10.1016/j.expneurol.2009.03.038. Epub 2009 Apr 5.

    PubMed 19348793

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct-current stimulation (tDCS) in people with Auditory Hallucination and Schizophrenia, run by Manhattan Psychiatric Center at 1 site in United States.

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 10 inclusion and 14 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: finished, as of the sponsor's last update on 4 Apr 2018. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction on the severity of auditory verbal hallucinations (time frame: 8 weeks). 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 NCT03485131, 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 4 Apr 2018.

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