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Targeting Auditory Hallucinations With Alternating Current Stimulation (STILL3)

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ClinicalTrials.gov Identifier: NCT03221270
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : January 25, 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 alternating current stimulation (tACS) as a treatment for auditory hallucinations in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizo Affective Disorder Device: tACS (alpha) Device: Sham tACS (alpha) Not Applicable

Detailed Description:
The investigator's primary objective is to provide further evidence for the effectiveness of transcranial alternating current stimulation (tACS) to treat auditory hallucinations and to collect preliminary data on whether maintenance stimulation sessions can prolong the duration of stimulation-induced clinical benefits. The investigators will be looking into effects of tACS to re-normalize pathological alpha oscillations in the dorso-lateral prefrontal cortex (dl-PFC) of patients with schizophrenia or schizo-affective disorder by comparing Auditory Hallucination Rating Scale (AHRS) scores immediately before the first stimulation session, immediately after the last stimulation session, and at the end of the 8 weeks of maintenance sessions. As a secondary objective, the investigators will assess the differential clinical effects of active sham and 10Hz tACS on electroencephalogram (EEG) measures of alpha oscillations. The investigators will also be using source localization techniques in EEG analysis, based on individual locations of the scalp electrodes and anatomical structures with the use of structural magnetic resonance imaging (sMRI).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will initially be randomized to either sham or 10 Hz tACS for the 5 consecutive days of stimulation. Participants will then be re-randomized to either sham or 10 Hz tACS for the 8 weeks of maintenance stimulation.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double blind, randomized clinical trial.
Primary Purpose: Treatment
Official Title: Targeting Auditory Hallucinations With Alternating Current Stimulation
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: tACS (alpha)
20 participants: 10 Hz tACS with a peak-to-peak amplitude of 2mA for 20 minutes twice daily during 5 consecutive days of stimulation, then 40 minutes once weekly for 8 weeks of maintenance stimulation.
Device: tACS (alpha)
Neuroconn DC Stimulator

Sham Comparator: Sham tACS (alpha)
20 participants: Will include 10 seconds of ramp in to 1 minute of 10 Hz tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation, then once weekly for 8 weeks of maintenance stimulation.
Device: Sham tACS (alpha)
Neuroconn DC Stimulator




Primary Outcome Measures :
  1. Auditory Hallucination Rating Scale (AHRS) [ Time Frame: 5 days from baseline measurement ]
    The investigators will compare the AHRS scores from immediately before the first stimulation (baseline) and immediately after the last stimulation as the primary outcomes measure.


Secondary Outcome Measures :
  1. Electroencephalogram (EEG) [ Time Frame: Change across time from baseline measurement to final maintenance stimulation ]
    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 1st, 3rd, and final maintenance stimulation visits.

  2. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 5 days from baseline measurement ]
    The investigators will compare the PANSS scores from immediately before the first stimulation (baseline) and immediately after the last stimulation.

  3. Brief Assessment Cognition in Schizophrenia (BACS) [ Time Frame: 5 days from baseline measurement ]
    The investigators will compare the BACS scores immediately before the first stimulation (baseline) and immediately after the last stimulation.


Other Outcome Measures:
  1. Electroencephalogram (EEG) Auditory Task [ Time Frame: Change across time from baseline measurement to final maintenance stimulation ]
    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 1st, 3rd, and final maintenance stimulation visits.

  2. Auditory Hallucination Rating Scale (AHRS) [ Time Frame: Change from Baseline AHRS at final maintenance stimulation session. ]
    The investigators will compare the AHRS scores from baseline across the 8 weeks of maintenance stimulation sessions as an outcome measure.

  3. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Change from Baseline PANSS at final maintenance stimulation session. ]
    The investigators will compare the PANSS scores from baseline across the 8 weeks of maintenance stimulation sessions as an outcome measure.

  4. Brief Assessment Cognition in Schizophrenia (BACS) [ Time Frame: Change from Baseline BACS at final maintenance stimulation session. ]
    The investigators will compare the BACS scores from baseline across the 8 weeks of maintenance stimulation sessions as an outcome measure.



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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 hallucinations. Duration of illness >1 year
  • 18 - 70 years old
  • Clinical stable for at least 12 weeks i.e. not requiring any hospitalization or a change in level of care
  • On current antipsychotic doses for at least 4 weeks
  • Experience at least 3 auditory hallucinations per week
  • 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 the informed consent on the patient's behalf with the patient providing written assent to participate

Exclusion Criteria:

  • DSM-IV diagnosis of alcohol or 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
  • Positive urine test of cannabis, cocaine, amphetamine, barbiturates, opiates
  • Current treatment (within 4 weeks) with psychotropic agents including benzodiazepines that are taken on a daily basis (limit prn use to greater than 48 hours before participating in a study session) or any of the following medications: carbamazepine, gabapentin, lamotrigine, and valproic acid
  • 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
  • A difference of greater than 20% in AHRS scores between screening visits
  • 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 appropriate birth control measures during study participation
  • Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participants' full compliance with or completion of the study

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): NCT03221270


Contacts
Contact: Anthony Criscitiello, BA 919-966-9929 anthony_criscitiello@med.unc.edu
Contact: Morgan Alexander, BS,BA 919-966-4755 morgan_alexander@med.unc.edu

Locations
United States, North Carolina
UNC Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Anthony Criscitiello, BA    919-966-9929    anthony_criscitiello@med.unc.edu   
Contact: Morgan Alexander, BS,BA    919-966-4755    morgan_alexander@med.unc.edu   
Principal Investigator: Flavio Frohlich, PhD         
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

Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03221270     History of Changes
Other Study ID Numbers: 17-1364
4R33MH105574-03 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
tACS
Sham
Auditory Hallucinations
Schizophrenia
Schizo Affective Disorder
EEG

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