An interventional study of tACS combined with 40 Hz sound stimulation and Transcranial alternating current stimulation in Alzheimer Disease, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment
Alzheimer's disease is characterized by progressive cognitive decline, and cognition is associated with cerebral concussion. Previous studies have found reduced gamma energy in the brain of AD patients. Therefore, modulation of gamma activity in AD patients may help improve cognitive function.
The purpose of this study was to investigate the safety and tolerability of transcranial alternating current stimulation (tACS) combined with 40Hz sound stimulation in patients with mild to moderate Alzheimer's disease (AD); to compare the effects of tACS combined with sound stimulation, tACS, and 40Hz sound stimulation on cognition in AD patients; and the effects of tACS combined with sound stimulation, tACS, and 40Hz sound stimulation on brain network connectivity in AD patients before and after tACS.
The number of people with Alzheimer's disease is increasing every year, but the available drugs are not effective. Both transcranial alternating current stimulation (tACS) and sound stimulation are non-invasive methods to modulate Central Nervous System excitability. tACS has been shown to modulate cognitive processes by affecting intrinsic oscillatory manipulation and entrainment in the brain. And 40 Hz sound stimulation reduces Aβ amyloid deposition in the hippocampus of AD mice.
Sixty patients with mild-to-moderate AD will be recruited in this randomized, double-blind, controlled study. The researchers will evaluate whether tACS (40Hz) to the DLPFC region or 40Hz sound stimulation to both ears improves cognition in patients with mild to moderate AD. The study will also investigate which stimulation method has a more pronounced and sustained improvement in cognition in the following three groups of patients.
Subjects will be randomized into three groups, with the first group receiving tACS combined with sound stimulation, the second group receiving tACS alone, and the third group receiving sound stimulation alone. All will receive three weeks (15 sessions) of treatment. Patients will be assessed by neuropsychological testing at baseline, post-treatment (21 days) and at the 3-month follow-up. Subjects will be compared by functional MRI at baseline and post-treatment for brain network connectivity before and after treatment.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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Exclusion Criteria:
15 daily (Monday-Friday) 20min sessions of tACS combined with 40 Hz sound stimulation
Device: tACS combined with 40 Hz sound stimulation
15 daily (Monday-Friday) 20min sessions of tACS stimulation
Device: Transcranial alternating current stimulation
15 daily (Monday-Friday) 20min sessions of 40 Hz sound stimulation
Device: 40 Hz sound stimulation
The tACS instrument (model: XPNS208-B). Two electrodes are placed in the dorsolateral prefrontal cortex and the contralateral supraorbital area. and connected to the tACS device via a thin cable. The intervention will be performed using tACS (40 Hz, 1.5 mA) for 15 sessions of 20 min over 3 weeks (21 days). Sound stimulation apparatus: Two sponge earplugs were placed in the ears and the sound stimulator was set to (40Hz, 60dB). Sound stimulation was turned on simultaneously at the beginning of tACS. The duration of sound stimulation was set to 5 min stimulation, 5 min rest, 5 min stimulation, 1 min rest, and continued stimulation until the end of electrical stimulation while sound stimulation was turned off.
The tACS instrument (model: XPNS208-B). Two electrodes are placed in the dorsolateral prefrontal cortex and the contralateral supraorbital area. and connected to the tACS device via a thin cable. The intervention will be performed using tACS (40 Hz, 1.5 mA) for 15 sessions of 20 min over 3 weeks (21 days).
Sound stimulation apparatus: Two sponge earplugs were placed in the ears and the sound stimulator was set to (40Hz, 60dB). The duration of the sound stimulation was set to stimulate for 5 min, rest for 5 min, stimulate for 5 min, rest for 1 min, and last for a total of 20 min. 15 sessions of 20 min were performed over a period of 3 weeks (21 days).
Change in Alzheimer's Disease Assessment Scale cognitive subscale scores
ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.
Time frame: up to 21 days (end of intervention) ,3 months
Change in Montreal Cognitive Assessment scores
Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
Time frame: up to 21 days (end of intervention) ,3 months
Change in Mini-mental State Examination scores
Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and higher value represents a better outcome.
Time frame: up to 21 days (end of intervention) ,3 months
Change in Clinical Dementia Rating scores
Clinical Dementia Rating(CDR) will be used to evaluate the level of dementia in AD patients. Mild dementia CDR: 1.0; Moderate dementia CDR: 2.0; Severe dementia CDR: 3.0.
Time frame: up to 21 days (end of intervention) ,3 months
Change in Auditory Verbal Learning Test scores
auditory verbal learning test（AVLT）will be used to evaluate the memory function. AVLT ranges from 0 to 36, and higher values representing better outcome.
Time frame: up to 21 days (end of intervention) ,3 months
Change in Boston Naming Test scores
Boston Naming Test（BNT-30） will be used to assess language function. It ranges from 0 to 30, and higher value represents a better outcome.
Time frame: up to 21 days (end of intervention), 3 months
Change in Neuropsychiatric Inventory (NPI) scores
The Neuropsychiatric Inventory will be used to measure neuropsychiatric symptoms. It ranges from 0 to 144, and higher value represents a worse outcome.
Time frame: up to 21 days (end of intervention), 3 months
Change in Activities of Daily Living scores
Activities of Daily Living (ADL) scale will be used to assess the change of life quality. It ranges from 20 to 80. The "20" represents normal life ability and the higher score presents the worse life ability.
Time frame: up to 21 days (end of intervention), 3 months
Change in Magnetic Resonance Imaging performance
Function Magnetic Resonance Imaging (fMRI) will be used to measure changes in brain connectivity；Structural Magnetic Resonance Imaging (sMRI) will be used to measures structural changes in the brain.
Time frame: up to 21 days (end of intervention), 3 months
Incidence of tACS Adverse events
Adverse Events as a result of tACS stimulation will be reported.
Time frame: up to 21 days (end of intervention), 3 months
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Chinese PLA General Hospital