Effects of Gamma-tACS on Memory and Sleep

Not Applicable

Completed

• Conditions: Cognitive Decline; Memory; Sleep; Transcranial Alternating Current Stimulation; Aging
• Interventions: Device: Gamma transcranial alternating current stimulation; Device: Control transcranial alternating current stimulation; Device: EEG headband; Device: Actigraphy wristband

• Registration Number: NCT05907707
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The purpose of this clinical trial is to investigate the feasibility and efficacy of non-invasive transcranial alternating current stimulation (tACS) at gamma frequency in enhancing memory recall and modulating sleep network dynamics measured by at-home electroencephalography (EEG) in healthy elderly people. Eligible participants will first collect sleep EEG at home for one night to acclimate to the data collection during sleep. Participants are then randomized into first undergoing either tACS at gamma band frequencies (i.e. 40Hz) or tACS at a control frequency (i.e. 21Hz). Stimulation is administered in the lab during a cognitive testing battery that includes memorizing items. After a night of sleep with EEG at home, participants return to the lab the following day to measure memory recall. Recall is performed again after five days. This sequence of encoding during stimulation in the lab, sleep EEG at home for one night, and recall is then repeated for the other stimulation condition about a week later. Participants are wearing an actigraphy wristband throughout the study period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-18
• Study Start: 2023-06-28
• Primary Completion: 2023-12-28
• Study Completion: 2023-12-28
• Status Verified: 2024-11
• Results First Submitted: 2024-11-21
• Results First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Results First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• >50 years old

Read More

Exclusion Criteria

• Implanted device or metal in head (including cochlear implant or other hearing aid), cardiac pacemaker or any other powered medical device
• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First active control (21 Hz) stimulation, then gamma (40 Hz) stimulation	Actigraphy wristband	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.
First gamma (40Hz) stimulation, then active control (21Hz) stimulation	Gamma transcranial alternating current 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.
First gamma (40Hz) stimulation, then active control (21Hz) stimulation	Control transcranial alternating current 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.
First gamma (40Hz) stimulation, then active control (21Hz) stimulation	EEG headband	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.
First gamma (40Hz) stimulation, then active control (21Hz) stimulation	Actigraphy wristband	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.
First active control (21 Hz) stimulation, then gamma (40 Hz) stimulation	Control transcranial alternating current 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.
First active control (21 Hz) stimulation, then gamma (40 Hz) stimulation	EEG headband	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.
First active control (21 Hz) stimulation, then gamma (40 Hz) stimulation	Gamma transcranial alternating current 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.

Primary Outcome Measures

Name	Time	Method
Percent of Participants Tolerating Cognitive Testing During tACS	Baseline (Day 1)	To establish acceptability of tACS combined with cognitive testing in healthy elderly participants and will be considered acceptable if at least \>/= 80% of participants tolerate the procedure.
Verbal Memory at Day 1	Baseline (Day 1)	Participants will memorize 15 words ("Rey Auditory Verbal Learning Test") during gamma-tACS or control-tACS. They will be required to recall the words on the same day. The number of correctly remembered words will be recorded.
Verbal Memory at Day 2	Follow-Up (Day 2)	Participants will memorize 15 words ("Rey Auditory Verbal Learning Test") during gamma-tACS or control-tACS. They will be required to recall the words on the day after. The number of correctly remembered words will be recorded.
Verbal Memory at Day 5	Follow-Up (Day 5)	Participants will memorize 15 words ("Rey Auditory Verbal Learning Test") during gamma-tACS or control-tACS. They will be required to recall the words after 5 days. The number of correctly remembered words will be recorded.
Associative Verbal Memory at Day 1	Baseline (Day 1)	Participants will memorize 8 word-pairs during gamma-tACS or control-tACS. They will be required to recall the pairs on the same day. The number of correctly remembered word pairs will be recorded.
Associative Verbal Memory at Day 2	Follow-Up (Day 2)	Participants will memorize 8 word-pairs during gamma-tACS or control-tACS. They will be required to recall the pairs on the day after. The number of correctly remembered word pairs will be recorded.
Associative Verbal Memory at Day 5	Follow-Up (Day 5)	Participants will memorize 8 word-pairs during gamma-tACS or control-tACS. They will be required to recall the pairs after 5 days. The number of correctly remembered word pairs will be recorded.
Percentage of Participants in Which it is Possible to Obtain at Least 4 Hours EEG Recording	Baseline (Day 1)	To establish feasibility of at-home use of a single-channel EEG device during sleep. This will be considered feasible if the device has been worn for at least 4 hours during the first night for \>/= 80% of participants.
Percentage of Participants Who Wear the EEG Device During All Three Nights for at Least 4 Hours	Baseline (Day 1)	To establish acceptability of at-home use of the single-channel EEG device during multiple nights. Acceptability will be considered as given if the device has been worn for at least 4 hours during each of the three nights in \>/=80% of participants.
Amount of Sleep Spindles in Sleep-EEG	Baseline (Day 1)	To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on the number of sleep spindles occuring during the night after the intervention. Sleep spindles during the first two hours of sleep-EEG will be counted.
Amount of Slow Wave Sleep in Sleep-EEG	Baseline (Day 1)	To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on the amount of slow wave sleep (deep/delta sleep) occuring during the night after the intervention. The amount of slow wave sleep during the first two hours of sleep-EEG will be counted.

Secondary Outcome Measures

Name	Time	Method
Performance in Phonematic Fluency-Correct Words	Baseline (Day 1), Follow-Up (Day 2)	To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on a phonematic fluency-task during 1 minute. The number of correct words will be calculated.
Performance in Phonematic Fluency-Perseverations	Baseline (Day 1), Follow-Up (Day 2)	To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on a phonematic fluency-task during 1 minute. Number of correct words, number of perseverations and number of rule breaks will be calculated.
Performance in Phonematic Fluency-Rule Breaks	Baseline (Day 1), Follow-Up (Day 2)	To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on a phonematic fluency-task during 1 minute. Number of correct words, number of perseverations and number of rule breaks will be calculated.
Executive Functioning (Time to Complete Stroop Test)	Baseline (Day 1), Follow-Up (Day 2)	To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on the Stroop Color and Word Test during and on the day after the intervention. Time for test completion and errors will be calculated. Selective attention was evaluated with the Stroop Color Word Interference Test. In the interference portion of this test, the subject identifies the color of ink in which words ("red", "green", or "blue") are printed, requiring the subject to inhibit their natural tendency to read the word. A subject's score is the time taken to identify 50 stimulus items. The time taken to complete the maze is inversely proportional to the cognitive function.
Executive Functioning (Trail Making Test)	Baseline (Day 1), Follow-Up (Day 2)	To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on the Trail Making Test (TMT) during and on the day after the intervention. The TMT (Part A and Part B) is a measure of visuomotor processing/sequencing speed. Participants must draw a line connecting numbers in ascending order as quickly as possible. Completion time in seconds is recorded (0-120, where lower scores represent better performance). Completion time of Part B is divided by completion time of Part A (Ratio B/A).
Attentional Performance (TAP)	Baseline (Day 1), Follow-Up (Day 2)	To investigate the effect of a single session of gamma-tACS (compared to control-tACS) on subtests of the Test of Attentional Performance (TAP) during and on the day after the intervention. Percentile ranks for the following subtests will be calculated: Alertness, Go/NoGo, Divided Attention, Visual Scanning.

Trial Locations

Locations (1)

Carolina Center for Neurostimulation; 🇺🇸 Chapel Hill, North Carolina, United States