NCT02360228

Brief Summary

Investigating the effects of non-invasive transcranial current stimulation as a treatment for auditory hallucinations in patients with schizophrenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 27, 2018

Completed
Last Updated

April 27, 2018

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

February 2, 2015

Results QC Date

January 25, 2018

Last Update Submit

April 15, 2018

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

tACStDCSshamauditory hallucinationsSchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score

    The Auditory Hallucination Rating Scale (AHRS) measures the severity of auditory hallucinations in the past week. The scale assesses frequency, duration, location, loudness, belief of origin of voices, negative content, distress, disruption to life, and control over voices. All items are measured on a scale of 0 to 4, with a total possible score of 44. Higher scores indicate higher severity of auditory hallucinations. The investigators will compare the AHRS scores from immediately before the first stimulation and immediately after the last stimulation session as the investigator's primary outcomes measure.

    Baseline, five days post baseline, 2 weeks post baseline, 5 weeks post baseline

Secondary Outcomes (4)

  • Change in Alpha Oscillations Measured With Electroencephalogram (EEG) Resting State From Baseline

    Baseline, five days post baseline

  • Change in Positive and Negative Syndrome Scale (PANSS) Scores

    baseline, five days post baseline, five weeks post baseline

  • Change in Brief Assessment of Cognition in Schizophrenia (BACS) Score

    baseline, five days post baseline, five weeks post baseline

  • Change in Peak Frequency of Functional Connectivity From Baseline Measured With Electroencephalogram (EEG) Resting State

    Baseline, five days post baseline

Other Outcomes (2)

  • Change in Electroencephalogram (EEG) Auditory Tasks: Oddball Task From Baseline

    baseline, five days post baseline

  • Change in Electroencephalogram (EEG) Auditory Tasks: Click Train Task From Baseline

    baseline, five days post baseline

Study Arms (3)

tACS (alpha)

EXPERIMENTAL

20 participants: 10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily

Device: tACS (alpha)

tDCS

EXPERIMENTAL

20 participants: 2mA stimulation for 20 minutes twice daily

Device: tDCS

Sham stimulation

SHAM COMPARATOR

20 participants: Will include 10 seconds of ramp in to 1 minutes of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily.

Device: tACS (alpha)

Interventions

tACS (alpha)DEVICE
Sham stimulationtACS (alpha)
tDCSDEVICE
tDCS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness \>1 year
  • years old
  • Clinically stable for at least 12 weeks, i.e. not requiring hospitalization or a change in level of care
  • On current antipsychotic doses for at least 4 weeks
  • Stable auditory hallucinations as demonstrated by having less than or equal to 20% change in AHRS scores across a 2 week interval during the screening period.
  • Capacity to understand all relevant risks and potential benefits of the study and to provide written informed consent, OR has a legal guardian who can provide informed consent on the patient's behalf with the patient providing written assent to participate.

You may not qualify if:

  • DSM-IV diagnosis of alcohol of substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
  • Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation
  • History of traumatic brain injury that required subsequent cognitive rehabilitation, or caused cognitive sequelae
  • Prior brain surgery
  • Any brain devices/implants, including cochlear implants and aneurysm clips
  • Co-morbid neurological condition (e.g. seizure disorder, brain tumor)
  • Non English speakers
  • Female participants who are pregnant, nursing, or unwilling to use an adequate method of contraception during study participation for those of childbearing potential
  • Positive urine test for cannabis, cocaine, amphetamine, barbiturates, benzodiazepines, opiates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.

    PMID: 22581236BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersHallucinations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Dr. Flavio Frohlich
Organization
University of North Carolina at Chapel Hill
flavio_frohlich@med.unc.edu
(919) 966-4584

Study Officials

  • Flavio Frohlich, PhD

    University of North Carolina at Chapel Hill - Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 10, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

April 27, 2018

Results First Posted

April 27, 2018

Record last verified: 2016-03

Locations

US(1)