Study Results
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View full resultsBasic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2023-06-28
2023-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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First gamma (40Hz) stimulation, then active control (21Hz) stimulation
After collecting sleep EEG at home for one night to acclimate to the data collection during sleep, participants first receive gamma (40Hz) tACS on Day 1 followed by a 5-9 day washout. Participants then receive active control (21Hz) stimulation.
Gamma transcranial alternating current stimulation
tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Control transcranial alternating current stimulation
tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
EEG headband
At-home, ambulatory, single-channel EEG headband which records brain activity during sleep
Actigraphy wristband
At-home, ambulatory, wrist-worn accelerometer which records levels of motor activity during the whole day
First active control (21 Hz) stimulation, then gamma (40 Hz) stimulation
After collecting sleep EEG at home for one night to acclimate to the data collection during sleep, participants first receive active control (21Hz) tACS on Day 1 followed by a 5-9 day washout. Participants then receive gamma (40Hz) stimulation.
Gamma transcranial alternating current stimulation
tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Control transcranial alternating current stimulation
tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
EEG headband
At-home, ambulatory, single-channel EEG headband which records brain activity during sleep
Actigraphy wristband
At-home, ambulatory, wrist-worn accelerometer which records levels of motor activity during the whole day
Interventions
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Gamma transcranial alternating current stimulation
tACS (gamma frequency, 40Hz) during cognitive testing (about 40 minutes duration).
Control transcranial alternating current stimulation
tACS (control frequency, 21Hz) during cognitive testing (about 40 minutes duration).
EEG headband
At-home, ambulatory, single-channel EEG headband which records brain activity during sleep
Actigraphy wristband
At-home, ambulatory, wrist-worn accelerometer which records levels of motor activity during the whole day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known neurological disease from history (epilepsy, sleep disorder (insomnia, sleep apnea, restless legs syndrome, parasomnia), stroke or transitory ischemic attack, cognitive impairment, neurodegenerative disease (for example Alzheimer's disease, Parkinson's disease or amyotrophic lateral sclerosis), immune-mediated disease of the central nervous system, chronic infectious brain disease, brain tumor, traumatic brain injury with loss of consciousness and/or intracranial bleeding, chronic pain with the need for daily analgesic use)
* Positive screening for epilepsy (questionnaire)
* Pathological Montreal Cognitive Assessment (MoCA \<26/30 points)
* Brain surgery in the past (lifetime)
* Known psychiatric disorder from history (schizophrenia (lifetime), obsessive compulsive disorder (OCD; lifetime), borderline personality disorder (lifetime), anxiety disorder (lifetime), bipolar disorder (lifetime), psychosis (lifetime), eating disorder (lifetime), depression (within the last three months)
* Positive screening for anxiety disorder (GAD-7 ≥10/21 points) or positive screening for depression (PHQ-9 ≥5/27 points)
* Known other relevant medical condition from history (moderate to severe chronic obstructive pulmonary disease (COPD), abnormal kidney function (defined as estimated Glomerular Filtration Rate \<60ml/min), current liver disease (defined as hepatitis and/or liver cirrhosis), cancer, diabetes mellitus, cardiac disease (heart failure, myocardial infarct, atrial fibrillation and revascularization - all within the last three months)
* Working in night shifts or going to bed after midnight on 3 or more nights per week
* Positive screening for sleep disorder (PSQI \>5/21 points)
* Psychotropic treatment or illegal drugs (including cannabis) within the last three months
* Indication for alcohol use disorder: AUDIT score (Alcohol Use Disorders Identification Test; screening for unhealthy alcohol use) ≥7 for females and for males ≥ 65 years or ≥8 for males \<65 years
* Not willing to abstain alcohol at least 24 hours before each study visit
* Pregnancy, planned pregnancy, fertility treatment planned or ongoing
* Having experienced an adverse event in the past after receiving Transcranial Magnetic Stimulation (TMS)
* If, after filling out a questionnaire on the participant's medical history that informs researchers of relevant events that marginally increase the risk of an adverse event occurring during TMS, researchers will exercise their expert judgement to determine whether that participant should be excluded
50 Years
ALL
Yes
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Flavio Frohlich, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Carolina Center for Neurostimulation
Chapel Hill, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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23-0597
Identifier Type: -
Identifier Source: org_study_id
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