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Exploring effect of novel non-invasive brain stimulation technique on brain activity and connectivity in individuals with early Alzheimer's disease.

Effect of high definition transcranial infraslow pink noise stimulation on cortical activity and functional connectivity in individuals with early Alzheimer's disease: A pilot randomised placebo-controlled study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001443886
Enrollment
18
Registered
2021-10-25
Start date
2021-11-01
Completion date
2022-01-28
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to explore the effect of a non-invasive external brain stimulation technique [Transcranial electrical stimulation (TES)] on corticial activity and functional connectivity in individuals with early Alzheimer's disease. The activity in the default mode network 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 key hubs of the default mode network. We hypothesize that this new stimulation technique will be able to alter the brain activity and connectivity at the targeted DMN regions, when compared to sham stimulation technique.

Interventions

High-definition transcranial infraslow pink noise stimulation (HD-tIPNS) targeting default mode network (posterior cingulate cortex) will be administered for a single session of 30 minutes 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 lyi

High-definition transcranial infraslow pink noise stimulation (HD-tIPNS) targeting default mode network (posterior cingulate cortex) will be administered for a single session of 30 minutes 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 32 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.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

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 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

Source: ANZCTR · Data processed: Feb 4, 2026