None listed
Conditions
Brief summary
Alzheimer’s disease (AD) is a disabling condition, affecting patient's autonomy and has a huge socio-economic impact. Current available treatments have small effect, warranting new treatment approaches. Several studies demonstrate altered activity in brain networks, in individuals with early AD. Transcranial electrical stimulation (TES), a non-invasive brain stimulation technique, can normalize abnormal activity in brain networks, thereby improve cognitive function. This study will investigate the safety, feasibility and explore the trend of effect effect of a novel TES technique (High definition transcranial infraslow grey noise stimulation), targeting multiple brain networks simultaneously (i.e., the triple network), on cognitive functioning in people with early AD and amnestic mild cognitive impairment. The outcomes of this study will help us to develop new brain stimulation treatments for early AD and amnestic mild cognitive impairment.
Interventions
High definition transcranial infraslow grey noise stimulation (HD-tIGNS) will be administered four times a week (30 min/session) for a total of 10 weeks (i.e., 40 sessions) by the researcher experienced in administering neuromodulation techniques. There are two arms of the study, namely a delayed start group and an early start group. Participants in the delayed start group will receive 5 weeks of sham stimulation, followed by 5 weeks of active stimulation. Participants in the early start group w
High definition transcranial infraslow grey noise stimulation (HD-tIGNS) will be administered four times a week (30 min/session) for a total of 10 weeks (i.e., 40 sessions) by the researcher experienced in administering neuromodulation techniques. There are two arms of the study, namely a delayed start group and an early start group. Participants in the delayed start group will receive 5 weeks of sham stimulation, followed by 5 weeks of active stimulation. Participants in the early start group will receive 10 weeks of active stimulation. The Starstim32 TCS device (Neuroelectrics, Spain) will be used to deliver stimulation while participants are comfortably and quietly seated. Stimulation electrodes will be placed identically during both the active stimulation phase and the sham stimulation phase, to target the anti-correlated activity of the key hubs of the triple network model (the salience network, the default mode network, the central executive network). For the active stimulation phase, the HD-tIGNS will be delivered at a current strength of maximum of 2mA for 30min, with 60s ramp up and ramp down at the beginning and the end of each stimulation session, with continuous stimulation in between. Adherence to the intervention will be recorded by the treating therapist and will be summarized as the percentage of the total number of sessions.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in the study, participants must meet all of the following inclusion criteria: • Capable of understanding and signing an informed consent form, as assessed by the informed consent questionnaire. • A diagnosis of ‘probable’ or ‘possible’ Alzheimer’s disease based on National Institute on Aging and Alzheimer’s Association (NIA-AA) guidelines or a diagnosis of amnestic mild cognitive impairment • A score of 0.5-1 in the Clinical Dementia Rating scale • A score of 72 points or higher on the Addenbrooke’s Cognitive Examination (ACE-III, a screening instrument for dementia) • A score higher than 18 points in the Mini-Mental State Exam (MMSE)
Exclusion criteria
Participants who meet any of the following conditions will be excluded: • History of epilepsy or seizures • History of stroke or tumour • Unstable medical or psychiatric conditions • Presence of any pacemaker or defibrillator • Presence of any metal implant in the body • Alcohol or substance abuse • Dyslipidaemia • History of uncontrolled/untreated hypertension • Participants who, in the opinion of the investigators, do not understand the information and procedures of the study, or would not be compliant with them. • Any participant for whom the investigators believe, for any reason, that participation would not be an acceptable risk.
Outcome results
None listed