None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and to explore the effect of a non-invasive external brain stimulation technique [Transcranial electrical stimulation (TES)] on cognition (e.g. memory, attention), function, and quality of life in individuals with early Alzheimer's disease. The activity in the brain region [posterior cingulate cortex (PCC)] targeted in the current study have been demonstrated to be altered in the very early stages of AD and are associated with cognitive dysfunctions. The TES technique has considerable potential as a treatment for AD due to its relatively low cost, safety, portability, and ease of use compared with other brain stimulation methods. We propose to explore a novel TES technique [high definition transcranial infraslow pink noise stimulation (HD-tIPNS)] targeting the PCC. The HD-tIPNS technique has been specifically developed in our Otago Brai3n laboratory to modulate the infraslow electrical activity (0.01-0.1 Hz) in the brain. The infraslow electrical activity, a fundamental frequency range of the brain, re-organises neurons, regulate oscillatory patterns in the brain during awake and sleep cycles, and improves the electrical connectivity of the brain-wide functional networks; thereby improve cognitive functioning. The evidence obtained from this study will thus help us to develop novel interventions to improve the health outcomes (cognition and function) in individuals with early AD.
Interventions
Transcranial electrical stimulation will be administered three times a week (30 minutes/ session) for a total of 8 weeks (i.e. 24 sessions in total) using a 32 channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain), by a researcher with health professional background and considerable experience in administering non-invasive neuromodulation techniques. The participants will be positioned comfortably and quietly in a seated/half lying position on a bed, and will wear a ne
Transcranial electrical stimulation will be administered three times a week (30 minutes/ session) for a total of 8 weeks (i.e. 24 sessions in total) using a 32 channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain), by a researcher with health professional background and considerable experience in administering non-invasive neuromodulation techniques. The participants will be positioned comfortably and quietly in a seated/half lying position on a bed, and will wear a neoprene head cap with circular stimulation electrodes placed on it. For the active treatment group, the stimulation will be delivered at a current strength of maximum of 2mA for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between. For sham stimulation, to create an identical skin sensation to the active stimulation, the current will be applied for a 60s ramp up (0-2mA) and 60s ramp down (2-0mA) at the beginning and the end of each stimulation session, without any current for the remainder of the stimulation period.
Sponsors
Dr Divya Adhia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Capable of understanding and signing an informed consent form • A diagnosis of ‘probable’ or ‘possible’ Alzheimer’s disease based on National Institute on Aging and Alzheimer’s Association (NIA-AA) guidelines • A score of 0.5 in the Clinical Dementia Rating scale • A score of 60 points or higher on the Cambridge Cognitive Examination (CAMCOG-a screening instrument for dementia) • A score higher than 18 points in the Mini-Mental State Exam (MMSE)
Exclusion criteria
• 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