PsychosisNCT04856657
Targeting Individual Alpha Frequencies to Enhance Perceptual Timing
An observational study of Psychosis and Schizophrenia, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Schizophrenia, Schizo Affective Disorder
- What is being tested?
- Transcranial alternating current stimulation
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 9 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will study individuals who experience psychosis, including schizophrenia, schizoaffective disorder, and bipolar disorder with psychosis.
Who may be able to join
- 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)
- Are age 18-64 (inclusive)
- Fluent in written and spoken English
Who cannot join
- 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
Show all 25Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Psychosis, Schizophrenia, Schizo Affective Disorder
- Being tested
- Transcranial alternating current stimulation
- Keywords
- tacs, neuromodulation, psychosis, schizophrenia
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Spondylocostal Dysostosis 4, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternating current stimulationDevice
Also called tACS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial alternating current stimulation | |
| 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. Receives: Device: Transcranial alternating current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double Flash Fusion Illusion Task
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).
Measured: 2 20-minute task runs (one during tACS at IAPF + 2 Hz and one during tACS at IAPF - 2 Hz)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Nov 2021
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856657
- Sponsor's protocol ID
- PSYCH-2021-29530
- Status last verified
- Feb 2023
- First submitted
- 13 Apr 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Individual Alpha Frequencies to Enhance Perceptual Timing
- ClinicalTrials.gov ID
- NCT04856657
- Acronym / sponsor ID
- PSYCH-2021-29530
- Conditions
- Psychosis, Schizophrenia, Schizo Affective Disorder
- Keywords
- tacs, neuromodulation, psychosis, schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Session 1: tACS at IAPF + 2 Hz | – | Device: Transcranial alternating current stimulationParticipants 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. |
| Session 1: tACS at IAPF - 2 Hz | – | Device: Transcranial alternating current stimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will study individuals who experience psychosis, including schizophrenia, schizoaffective disorder, and bipolar disorder with psychosis.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (25 listed)
- History of seizures or epilepsy
- Metallic cranial plates, screws, or implanted devices
- History of craniotomy
- History of stroke
- History of eczema on scalp
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial alternating current stimulationAlso: tACSThe 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. | Device | Session 1: tACS at IAPF + 2 Hz, Session 1: tACS at IAPF - 2 Hz |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and Schizophrenia, run by University of Minnesota 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 25 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 14 Feb 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2023.