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SchizophreniaSTILL3NCT03221270

Targeting Auditory Hallucinations With Alternating Current Stimulation

A study testing tACS treatment week and Maintenance tACS in people with Schizophrenia and Schizo Affective Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Schizophrenia, Schizo Affective Disorder
What is being tested?
tACS treatment week and Maintenance tACS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
14 Nov 2017to 5 Jan 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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

Read the 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).

Being tested
tACS treatment week, tACS sham week, Maintenance tACS, Maintenance Sham tACS
Keywords
tACS, Sham, Auditory Hallucinations, Schizophrenia, Schizo Affective Disorder, EEG
Medical subject headings
Schizophrenia, Psychotic Disorders, Hallucinations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tACS treatment weekDevice

    Also called Neuroconn DC Stimulator

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

  • tACS sham weekDevice

    Also called Neuroconn DC Stimulator

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

  • Maintenance tACSDevice

    Also called Neuroconn DC Stimulator

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

  • Maintenance Sham tACSDevice

    Also called Neuroconn DC Stimulator

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

Study groups in NCT03221270
Study groupRoleWhat they receive
tACS Treatment & tACS MaintenanceExperimental10 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.
Receives: Device: tACS treatment week; Device: Maintenance tACS
Sham tACS Treatment & Sham tACS MaintenanceSham comparator10 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.
Receives: Device: tACS sham week; Device: Maintenance Sham tACS
Sham tACS Treatment & tACS MaintenanceOther10 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.
Receives: Device: tACS sham week; Device: Maintenance tACS
tACS Treatment & Sham tACS MaintenanceOther10 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.
Receives: Device: tACS treatment week; Device: Maintenance Sham tACS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. 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.

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

  2. 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.

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start14 Nov 2017
  3. Primary completion5 Jan 2021
  4. Study completion5 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03221270
Sponsor's protocol ID
17-1364
Other IDs
4R33MH105574-03
Acronym
STILL3
Status last verified
Jan 2022
First submitted
14 Jul 2017
Last updated
16 Feb 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 22581236

  • 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.

    PubMed 26866874

Questions about this trial

What is this clinical trial studying?

A study testing tACS treatment week and Maintenance tACS in people with Schizophrenia and Schizo Affective Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Auditory Hallucination Rating Scale (AHRS) Score (time frame: Baseline, immediately after five days of stimulation, and immediately after the 8th week of maintenance stimulation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03221270, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.

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STILL3 Clinical Trial NCT03221270 | AzTrials