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Targeting Individual Alpha Frequencies to Enhance Perceptual Timing

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04856657
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
This is a single-blind randomized within-subject crossover design study that will be conducted in 2 phases. In Phase 1, up to 50 participants, after signing informed consent and determining eligibility, will undergo a baseline EEG and cognitive assessment. In Phase 2 participants will undergo tACS at IAF+2Hz, IAF-2Hz, and IAF during a double-flash illusion task in a randomized order. The tACS will be applied with a current of 1-2 mA (milliamperes) via two saline soaked electrode sponges (25 cm²) applied to the back of the head. The investigator's hypothesis is that participant's will perform better on the visual task while tACS is set to 2 Hz above their IAPF, relative to tACS set to 2 Hz below their IAPF.

Condition or disease Intervention/treatment
Psychosis Schizophrenia Schizo Affective Disorder Device: Transcranial alternating current stimulation

Detailed Description:

The proposed pilot study will assess the feasibility of transcranial alternating current stimulation (tACS) to enhance aspects of attention in people with psychotic disorders.

If a participant agrees to participate in this research, they will be asked to visit the study site to complete the activities listed below. These study activities will take about 5.5 hours to complete. The activities can be divided into up to 3 separate sessions as needed, but all activities should be completed within approximately one week.

Phase 1:

  • A clinical interview including an abbreviated MINI, consisting of the mood, mania, suicide, and psychosis modules to either: confirm a diagnosis of a psychotic disorder in Psychosis Subject recruits; or confirm no diagnosis of a psychotic disorder in Control Subject recruits. If any suicidal ideation is expressed on the suicide module, study staff will administer the C-SSRS.
  • All participants will complete the Wechsler Test of Adult Reading (WTAR) to obtain an estimate of average IQ, the Brief Assessment of Cognition (BAC app; including Verbal Learning, Digit Sequencing, Token Motor, Semantic Fluency, Symbol Coding, and Tower of London), the Edinburgh Handedness Inventory, and a brief demographic questionnaire.
  • Participants with psychosis will complete the PANSS clinical interview to assess psychosis symptoms. Controls will not complete the PANSS.
  • Next, participants will undergo a baseline EEG that includes measures of resting EEG (once at the beginning and once more at the end of the session) and a Double-Flash Fusion Illusion Task.

Phase 2:

  • Participants will undergo a shortened version of the Double-Flash task without any tACS stimulation.
  • Participants will then undergo 3 shortened versions of the Double-Flash Fusion Illusion task while simultaneously undergoing tACS. In counterbalanced order, participants will have tACS set at their IAF (obtained from the subject's resting EEG signal), their IAF + 2Hz and their IAF - 2 Hz. Each task run is expected to last 10-20 minutes. In the first ~1 minute of stimulation before starting the task, we will ask participants to report whether they are perceiving phosphenes. We will turn down the stimulation in .1 mA increments until the participant is no longer perceiving bothersome phosphenes before starting the task. Participants will have a ~40 minute break between task sessions.
  • During one of the 40 minute between session breaks, participants will be asked to perform two assessment versions of a time-order frequency judgment task: Sound Sweeps (auditory frequency modulation time-order judgement) and Visual Sweeps (visual gabor frequency modulation time-order judgement).
  • Following the third stimulation/task session, participants will respond to a questionnaire about the tolerability of the stimulation and whether they experienced any immediate adverse effects.

    • Currently, subjects will only undergo Phase 1 of the study to optimally pilot test the task and EEG procedures prior to enrolling subjects to both Phases which involves an experimental manipulation of the Double-Flash task. Phase 2 will be initiated at the discretion of the PI.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Targeting Individual Alpha Frequencies to Enhance Perceptual Timing
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022


Group/Cohort Intervention/treatment
Session 1: tACS at IAPF + 2 Hz
Participants in this arm will undergo tACS at a frequency 2 Hz above their IAPF during stimulation session 1. They will undergo tACS at a frequency 2 Hz below their IAPF during stimulation session 2.
Device: Transcranial alternating current stimulation
The tACS will be applied with a current of 1-2 mA (milliamperes) via two saline soaked electrode sponges (25 cm²) applied to the back of the head. The anode will be located at Oz and the cathode will be located at Cz.
Other Name: tACS

Session 1: tACS at IAPF - 2 Hz
Participants in this arm will undergo tACS at a frequency 2 Hz below their IAPF during stimulation session 1. They will undergo tACS at a frequency 2 Hz above their IAPF during stimulation session 2.
Device: Transcranial alternating current stimulation
The tACS will be applied with a current of 1-2 mA (milliamperes) via two saline soaked electrode sponges (25 cm²) applied to the back of the head. The anode will be located at Oz and the cathode will be located at Cz.
Other Name: tACS




Primary Outcome Measures :
  1. Double Flash Fusion Illusion Task [ Time Frame: 2 20-minute task runs (one during tACS at IAPF + 2 Hz and one during tACS at IAPF - 2 Hz) ]
    Participants are instructed to fixate their gaze on a central fixation cross. When the cue appears, a low-luminance disc stimulus flashes on either side (left or right) of the fixation cross. The disc can flash one or two times. After the stimulus ends, participants are cued to make a response regarding the number of disc flashes (1 or 2). Participants will undergo 300 trials. Participants will be scored on response accuracy (i.e., number of correct responses out of 300 possible responses).



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.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will study individuals who experience psychosis, including schizophrenia, schizoaffective disorder, and bipolar disorder with psychosis.
Criteria

Psychosis Participants:

Inclusion Criteria:

  • Meet diagnostic criteria for a psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder), as defined by the MINI (Mini-International Neuropsychiatric Interview)
  • Are age 18-64 (inclusive)
  • Fluent in written and spoken English
  • Have an outpatient status of at least 1 month prior to participation
  • Has been on a stable dose of psychiatric medication for at least one month prior to participation (titration to a lower dose of psychotropic medications under supervision of a psychiatrist can be allowed at the discretion of the investigators)

Exclusion Criteria:

  • History of seizures or epilepsy
  • Metallic cranial plates, screws, or implanted devices
  • History of craniotomy
  • History of stroke
  • History of eczema on scalp
  • Pre-existing sores or lesions at sites of tACS electrode placement
  • Non-removable facial piercings
  • Current or possibility of current pregnancy
  • Active suicidal ideation at screening or baseline assessments, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months, as indicated by the MINI and/or C-SSRS (All participants will complete the suicide module of the MINI. If participants express any suicidal ideation on the MINI, staff will complete the C-SSRS [Columbia-Suicide Severity Rating Scale].)
  • WTAR (Wechsler Test of Adult Reading) standardized score below 70
  • Any reason our tCS (transcranial stimulation) or EEG caps cannot be placed on their head

Control Participants:

Inclusion Criteria:

  • Are age 18-64 (inclusive)
  • Fluent in written and spoken English

Exclusion Criteria:

  • Meet diagnostic criteria for a psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder), as defined by the MINI
  • Self-reports having a first-degree relative with a psychotic disorder
  • History of seizures or epilepsy
  • Metallic cranial plates, screws, or implanted devices
  • History of craniotomy
  • History of stroke
  • History of eczema on scalp
  • Pre-existing sores or lesions at sites of tACS electrode placement
  • Non-removable facial piercings
  • Current or possibility of current pregnancy
  • Active suicidal ideation at screening or baseline assessments, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months, as indicated by the MINI and/or C-SSRS (All participants will complete the suicide module of the MINI. If participants express any suicidal ideation on the MINI, staff will complete the C-SSRS.)
  • WTAR standardized score below 70
  • Any reason our tCS or EEG caps cannot be placed on their head

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): NCT04856657


Contacts
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Contact: Areeb Kidwai 612-626-0953 kidwa010@umn.edu
Contact: Ian S Ramsay, PhD 612-672-6805 ramsa045@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Brandon Schermitzler         
Sponsors and Collaborators
University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04856657    
Other Study ID Numbers: PSYCH-2021-29530
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Minnesota:
tacs
neuromodulation
psychosis
schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders