Effects of Gamma-tACS on Memory and Sleep

Aging Clinical Trial

Official title:

Effects of Transcranial Alternating Current Stimulation (tACS) at Gamma Band Frequencies on Memory Recall and Sleep in Healthy Elderly Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05907707
• Other study ID #: 23-0597
• Status: Completed
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: December 28, 2023

Study information

• Verified date: June 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• >50 years old

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 TMS (Transcranial Magnetic Stimulation)

• 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

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction
• Memory
• Sleep
• Transcranial Alternating Current Stimulation

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Carolina Center for Neurostimulation	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploration of a Relationship (Correlation) between the Amount of Sleep Spindles and Slow Wave Sleep with Recall	A relationship is defined as a correlation (Pearson's) between memory recall performance (amount of words recalled) and sleep EEG features (especially spindles, slow waves), i.e., whether better memory recall is associated with more sleep spindles and more slow wave sleep in the night after stimulation.	Baseline (Day 1), Follow-Up (Day 2)
Other	Exploration of a Relationship (Correlation) of Sleep-Wake-Schedule changes and Type of Stimulation	To see whether there is a correlation (Pearson's) between type of stimulation/wearing EEG and the motor activity pattern (measured by actigraphy wristband).	Baseline (Day 1), Follow-Up (Day 2)
Primary	Percent of Participants Tolerating Cognitive Testing During tACS	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.	Baseline (Day 1)
Primary	Verbal Memory at 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.	Baseline (Day 1)
Primary	Verbal Memory at 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.	Follow-Up (Day 2)
Primary	Verbal Memory at 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.	Follow-Up (Day 5)
Primary	Associative Verbal Memory at 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.	Baseline (Day 1)
Primary	Associative Verbal Memory at 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.	Follow-Up (Day 2)
Primary	Associative Verbal Memory at 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.	Follow-Up (Day 5)
Primary	Proportion of Participants in which it is Possible to Obtain at Least 4 Hours EEG Recording	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.	Baseline (Day 1)
Primary	Proportion of Participants who Wear the EEG Device During all Three Nights for at Least 4 Hours	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.	Baseline (Day 1)
Primary	Amount of Sleep Spindles in Sleep-EEG	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.	Baseline (Day 1)
Primary	Amount of Slow Wave Sleep in Sleep-EEG	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.	Baseline (Day 1)
Secondary	Performance in Phonematic Fluency	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.	Baseline (Day 1), Follow-Up (Day 2)
Secondary	Executive Functioning (Stroop Test)	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.	Baseline (Day 1), Follow-Up (Day 2)
Secondary	Executive Functioning (Trail Making Test)	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. Time for test completion and errors will be calculated.	Baseline (Day 1), Follow-Up (Day 2)
Secondary	Attentional Performance (TAP)	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.	Baseline (Day 1), Follow-Up (Day 2)