Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001443886
Ethics application status
Approved
Date submitted
24/09/2021
Date registered
25/10/2021
Date last updated
25/10/2021
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring effect of novel non-invasive brain stimulation technique on brain activity and connectivity in individuals with early Alzheimer's disease.
Scientific title
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
Secondary ID [1] 305407 0
None
Universal Trial Number (UTN)
U1111-1269-7862
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Alzheimer's disease 323777 0
Condition category
Condition code
Neurological 321290 321290 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321817 0
Treatment: Devices
Comparator / control treatment
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.
Control group
Placebo

Outcomes
Primary outcome [1] 329070 0
Resting state Electroencephalography: Current density at the key hubs of the default mode network (Posterior Cingulate cortex, pregenual anterior cingulate cortex, and parahippocampal gyrus).
Timepoint [1] 329070 0
Baseline and immediately post-intervention
Primary outcome [2] 329071 0
Resting state Electroencephalography: Functional connectivity between the keys hubs of the default mode network (Posterior Cingulate cortex, pregenual anterior cingulate cortex, and parahippocampal gyrus).
Timepoint [2] 329071 0
Baseline and immediately post-intervention
Primary outcome [3] 329072 0
Any adverse events or side effects (e.g. tingling or burning under stimulation electrodes).

The following variables will be recorded:
•Qualitative description of each symptom
•The intensity of each symptom will be measured using a Likert scale ranging from 0 (none) to 10 (extreme)
•Relation of the symptom to the treatment, measured on a scale ranging from 1 (unrelated) to 5 (strongly related).
•Duration of each symptom and the time taken for resolution of each symptom, expressed in minutes.
•Worsening or improvement of any symptoms (DESS questionnaire).
•Any drop-outs due to adverse effects will also be recorded.
Timepoint [3] 329072 0
Immediately post treatment
Secondary outcome [1] 401341 0
None
Timepoint [1] 401341 0
NA

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
28/01/2022
Actual
Date of last data collection
Anticipated
28/01/2022
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 24148 0
New Zealand
State/province [1] 24148 0
Otago

Funding & Sponsors
Funding source category [1] 309769 0
University
Name [1] 309769 0
University of Otago
Country [1] 309769 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO BOX 56
University of Otago
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 310797 0
None
Name [1] 310797 0
Address [1] 310797 0
Country [1] 310797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309526 0
Southern Health and Disability Ethics Committe
Ethics committee address [1] 309526 0
Ethics committee country [1] 309526 0
New Zealand
Date submitted for ethics approval [1] 309526 0
Approval date [1] 309526 0
10/03/2020
Ethics approval number [1] 309526 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114462 0
Dr Divya Adhia
Address 114462 0
Department of Surgical Science,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand
Country 114462 0
New Zealand
Phone 114462 0
+64 211167594
Fax 114462 0
Email 114462 0
[email protected]
Contact person for public queries
Name 114463 0
Divya Adhia
Address 114463 0
Department of Surgical Science,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand
Country 114463 0
New Zealand
Phone 114463 0
+64 211167594
Fax 114463 0
Email 114463 0
[email protected]
Contact person for scientific queries
Name 114464 0
Divya Adhia
Address 114464 0
Department of Surgical Science,
Dunedin School of Medicine,
University of Otago.
PO Box 56.
Dunedin 9054, New Zealand
Country 114464 0
New Zealand
Phone 114464 0
+64 211167594
Fax 114464 0
Email 114464 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.