Sponsor study identifier
observational
11
1 country
1
Study Start
November 1, 2021
Actual (reported)Primary Completion
February 9, 2023
Actual (reported)Study Completion
February 9, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 9, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 13, 2021
Actual (reported)April 23, 2021
Actual (reported)November 1, 2021
Actual (reported)February 9, 2023
Actual (reported)February 9, 2023
Actual (reported)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).
2 20-minute task runs (one during tACS at IAPF + 2 Hz and one during 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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This study will study individuals who experience psychosis, including schizophrenia, schizoaffective disorder, and bipolar disorder with psychosis.
University of Minnesota
Minneapolis, Minnesota, 55455, United States
11 participants (actual enrollment reported by the registry).
First Submitted
April 13, 2021
First Posted
April 23, 2021
Study Start
November 1, 2021
Actual (reported)Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement
Contact the study team to confirm eligibility.
Primary Completion
February 9, 2023
Actual (reported)Study Completion
February 9, 2023
Actual (reported)Last Updated
February 14, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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