Targeting Auditory Hallucinations With Alternating Current Stimulation

NCT03221270 | Completed Results DMC FDA Device

• 2 other identifiers: 17-13644R33MH105574-03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia; Schizo Affective Disorder

Keywords

tACS; Sham; Auditory Hallucinations; Schizophrenia; Schizo Affective Disorder; EEG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Signal Change in the Average Alpha Oscillation Power From Eyes-Open Resting State Electroencephalogram (EEG)

  Change from baseline to immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.

• Average Score on the Positive and Negative Syndrome Scales (PANSS)

  Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.

• Brief Assessment Cognition in Schizophrenia (BACS)

  Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.

Other Outcomes (4)

• Electroencephalogram (EEG) Auditory Task

  Change across time from baseline measurement to final maintenance stimulation

• Auditory Hallucination Rating Scale (AHRS)

  Change from Baseline AHRS at final maintenance stimulation session.

• Positive and Negative Syndrome Scale (PANSS)

  Change from Baseline PANSS at final maintenance stimulation session.

Study Arms (4)

tACS Treatment & tACS Maintenance

EXPERIMENTAL

10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.

Device: tACS treatment week; Device: Maintenance tACS

Sham tACS Treatment & Sham tACS Maintenance

SHAM COMPARATOR

10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.

Device: tACS sham week; Device: Maintenance Sham tACS

Sham tACS Treatment & tACS Maintenance

OTHER

10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 40 minutes once weekly for 8 weeks of maintenance stimulation.

Device: tACS sham week; Device: Maintenance tACS

tACS Treatment & Sham tACS Maintenance

OTHER

10 Hz (alpha) tACS with a peak-to-peak amplitude of 2 mA for 20 minutes twice daily during 5 consecutive days of stimulation. 10 seconds of ramp in to 1 minute of 10 Hz (alpha) tACS with a ramp out of 10 seconds for a total of 80 seconds of stimulation once weekly for 8 weeks of maintenance stimulation.

Device: tACS treatment week; Device: Maintenance Sham tACS

Interventions

tACS treatment week DEVICE

10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 20 minutes twice for 5 consecutive days.

Also known as: Neuroconn DC Stimulator

tACS Treatment & Sham tACS Maintenance; tACS Treatment & tACS Maintenance

tACS sham week DEVICE

10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds twice a day for 5 consecutive days.

Also known as: Neuroconn DC Stimulator

Sham tACS Treatment & Sham tACS Maintenance; Sham tACS Treatment & tACS Maintenance

Maintenance tACS DEVICE

10 Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 40 minutes once a weekly for 8 weeks.

Also known as: Neuroconn DC Stimulator

Sham tACS Treatment & tACS Maintenance; tACS Treatment & tACS Maintenance

Maintenance Sham tACS DEVICE

10Hz sine wave stimulation with a peak-to-peak amplitude of 2 mA for 10 seconds once a week for 8 weeks.

Also known as: Neuroconn DC Stimulator

Sham tACS Treatment & Sham tACS Maintenance; tACS Treatment & Sham tACS Maintenance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• 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: 22581236 BACKGROUND

• Frohlich 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.

  PMID: 26866874 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rachel Force, PhD
• Organization: University of North Carolina at Chapel Hill

rachel_force@med.unc.edu

984-974-6239

Study Officials

• Flavio Frohlich, PhD

  University of North Carolina at Chapel Hill - Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double blind, randomized clinical trial.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: November 14, 2017
• Primary Completion: January 5, 2021
• Study Completion: January 5, 2021
• Last Updated: February 16, 2022
• Results First Posted: February 16, 2022

Record last verified: 2022-01

Locations

US (1)