ClinicalTrials.gov
ClinicalTrials.gov Menu

STimulation to Improve Auditory haLLucinations (STILL 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02360228
Recruitment Status : Completed
First Posted : February 10, 2015
Results First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Device: tACS (alpha) Device: tDCS Not Applicable

Detailed Description:
The investigator's primary objective is to conduct a pilot clinical trial to establish the feasibility and to collect first effectiveness data for the use of transcranial alternating current stimulation (tACS) to re-normalize pathological alpha oscillations in dorso-lateral prefrontal cortex (dl-PFC) of patients with schizophrenia or schizoaffective disorder by comparing Auditory Hallucination Rating Scale (AHRS) scores immediately before the first stimulation session and immediately after the last stimulation session. As a secondary objective the investigators will assess the differential clinical effects of sham, 10 Hz and 2 mA transcranial direct current stimulation (tDCS) on electroencephalogram (EEG) measures of alpha oscillations.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Auditory Hallucinations With Alternating Current Stimulation
Study Start Date : May 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: tACS (alpha)
20 participants: 10Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily
Device: tACS (alpha)
Experimental: tDCS
20 participants: 2mA stimulation for 20 minutes twice daily
Device: tDCS
Sham Comparator: Sham stimulation
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)



Primary Outcome Measures :
  1. Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score [ Time Frame: Baseline, five days post baseline, 2 weeks post baseline, 5 weeks post baseline ]
    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.


Secondary Outcome Measures :
  1. Change in Alpha Oscillations Measured With Electroencephalogram (EEG) Resting State From Baseline [ Time Frame: Baseline, five days post baseline ]
    The investigators will compare alpha oscillation power from resting state EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.

  2. Change in Positive and Negative Syndrome Scale (PANSS) Scores [ Time Frame: baseline, five days post baseline, five weeks post baseline ]
    The investigators will compare the PANSS total scores immediately before first stimulation session and immediately after last stimulation session as secondary outcome measures. Scores range from 30 to 210, with higher scores indicating more severe symptomology.

  3. Change in Brief Assessment of Cognition in Schizophrenia (BACS) Score [ Time Frame: baseline, five days post baseline, five weeks post baseline ]

    The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery of cognitive assessments assessing verbal memory and learning, working memory, motor function, verbal fluency, speed of processing, and executive function. Higher scores indicate better cognitive performance. The investigators will compare the BACS total scores immediately before first stimulation session and immediately after last stimulation session as secondary outcome measures.

    Verbal Memory: Score out of 75

    Digit Sequencing: Score out of 28

    Token Motor: Score out of 100

    Fluency: No score limit

    Symbol Coding: Score out of 110

    Tower of London: Score out of 22

    Reported score is the mean of these 6 subtests. Healthy controls (Keefe et al., 2006) scored 45.6 as a comparison.


  4. Change in Peak Frequency of Functional Connectivity From Baseline Measured With Electroencephalogram (EEG) Resting State [ Time Frame: Baseline, five days post baseline ]
    The investigators will compare peak frequency of functional connectivity from resting state EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze the change in peak frequency of functional connectivity as a pilot study for derivation of EEG biomarkers.


Other Outcome Measures:
  1. Change in Electroencephalogram (EEG) Auditory Tasks: Oddball Task From Baseline [ Time Frame: baseline, five days post baseline ]

    The investigators will compare auditory responses during auditory tasks EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers and look for increase in auditory responses.

    Auditory oddball paradigm is an experimental design that has standard (low-pitch) and deviant (high-pitch) stimuli. Differences in ERP from these two stimuli can measure functions of sensory processing. Patients with schizophrenia often exhibit abnormal responses to the stimuli thus its discrepancy compared to healthy human participants can be a hallmark of symptoms in schizophrenia.


  2. Change in Electroencephalogram (EEG) Auditory Tasks: Click Train Task From Baseline [ Time Frame: baseline, five days post baseline ]

    The investigators will compare auditory responses during auditory tasks EEG recordings on the first and last day of stimulation. The investigators will also collect this data at the one week and one month follow up visits.

    Auditory steady-state response (ASSR) from EEG data elicited by auditory click trains is considered as a hallmark of network dysfunction in schizophrenia. To obtain ASSR, auditory tones at a specific frequency (e.g., 40Hz) are presented for multiple trials and EEG data is analyzed to extract brain responses to the stimuli.

    One common way to extract the brain responses from this task is phase coherence between trials. When external stimuli (click trains) occur, brain signals are synchronized to these stimuli and its coherence should be the highest at the stimulation frequency. Phase information for calculating the coherence can be obtained by time-frequency analysis. Averaged coherence across the multiple trials can represent the inter-trial phase coherence.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness >1 year
  • 18-70 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360228


Locations
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Flavio Frohlich, PhD University of North Carolina at Chapel Hill - Department of Psychiatry
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02360228     History of Changes
Other Study ID Numbers: 14-3285
1R21MH105574-01 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2015    Key Record Dates
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018
Last Verified: March 2016

Keywords provided by University of North Carolina, Chapel Hill:
tACS
tDCS
sham
auditory hallucinations
Schizophrenia
Schizoaffective Disorder

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms