Schizophrenia Clinical Trial
— STILL3Official title:
Targeting Auditory Hallucinations With Alternating Current Stimulation
Verified date | January 2022 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigating the effects of non-invasive transcranial alternating current stimulation (tACS) as a treatment for auditory hallucinations in patients with schizophrenia.
Status | Completed |
Enrollment | 25 |
Est. completion date | January 5, 2021 |
Est. primary completion date | January 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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) - 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 |
Country | Name | City | State |
---|---|---|---|
United States | UNC Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Mental Health (NIMH) |
United States,
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. Erratum in: Am J Psychiatry. 2012 Dec 1;169(12):1321. — View Citation
Fröhlich F, Burrello TN, Mellin JM, Cordle AL, Lustenberger CM, Gilmore JH, Jarskog LF. Exploratory study of once-daily transcranial direct current stimulation (tDCS) as a treatment for auditory hallucinations in schizophrenia. Eur Psychiatry. 2016 Mar;33:54-60. doi: 10.1016/j.eurpsy.2015.11.005. Epub 2016 Feb 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Electroencephalogram (EEG) Auditory Task | 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. | Change across time from baseline measurement to final maintenance stimulation | |
Other | Auditory Hallucination Rating Scale (AHRS) | The investigators will compare the AHRS scores from baseline across the 8 weeks of maintenance stimulation sessions as an outcome measure. | Change from Baseline AHRS at final maintenance stimulation session. | |
Other | Positive and Negative Syndrome Scale (PANSS) | The investigators will compare the PANSS scores from baseline across the 8 weeks of maintenance stimulation sessions as an outcome measure. | Change from Baseline PANSS at final maintenance stimulation session. | |
Other | Brief Assessment Cognition in Schizophrenia (BACS) | The investigators will compare the BACS scores from baseline across the 8 weeks of maintenance stimulation sessions as an outcome measure. | Change from Baseline BACS at final maintenance stimulation session. | |
Primary | Mean Auditory Hallucination Rating Scale (AHRS) Score | The Auditory Hallucination Rating Scale (AHRS) measures the severity of auditory hallucinations in the past week. The scale assess 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. | Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation. | |
Secondary | Percentage of Signal Change in the Average Alpha Oscillation Power From Eyes-Open Resting State Electroencephalogram (EEG) | Eyes-open but at rest EEG data was sampled using a 128-channel Geodesic EEG system. Alpha power spectral density was estimated using the Welch's method (in 2s Hamming windows with 0.5s overlap and 0.1 Hz spectral resolution). Aperiodic components were removed before extracting the individual alpha frequency (IAF; peak with the highest power density between 7 to 12 Hz, with consistent presence during the eyes-open blocks across all sessions). All spectra were visually inspected to confirm IAF choice. We computed the percent signal change of alpha power for each session relative to the baseline session:% change_n=(P_baseline-P_n)/P_baseline where P_n is the alpha power in the n-th session, and P_baseline is the alpha power in the baseline session. | Change from baseline to immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation. | |
Secondary | Average Score on the Positive and Negative Syndrome Scales (PANSS) | The Positive and Negative Syndrome Scale (PANSS) is a 30-item clinician-administered scale. Each item is scored on a seven point scale, representing increasing levels of psychopathology (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme). Each item is rated in consultation with the definitions and criteria provided in the manual. Seven items constitute the positive scale, seven items make up the negative scale, and the remaining sixteen make up a general psychopathology scale. Therefore, the potential ranges are 7 to 49 for both positive and negative scales, and 16 to 112 for the General Psychopathology Scale. | Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation. | |
Secondary | Brief Assessment Cognition in Schizophrenia (BACS) | The Brief Assessment of Cognition in Schizophrenia (BACS) is a clinically administered pen- and -paper battery of neurocognitive tests. The tasks administered in person included verbal memory, digit sequencing, token motor task, semantic fluency, letter fluency, symbol coding, and the tower of London task. The scores on each subtest were not normalized or scaled, values from each test were summed. In this sample the total summed scores ranged 112-296 with a standard deviation of 39.61. Higher values represent greater cognitive performance. | Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation. |
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