None listed
Conditions
Brief summary
Cognitive disorders, are significant and growing health challenge, due to an ageing population and an increase in incidence of dementias. Alterations in resting-state triple brain networks have been demonstrated by several functional brain imaging studies in people with cognitive disorders. The triple brain networks comprises of the default-mode network (DMN), salience network (SN), and the central executive network (CEN), which are critical for memory and cognitive functioning. Recent evidence suggests that altered anti-correlated activity patterns in triple brain networks are associated with cognitive dysfunctions and disease progression. Interventions targeting triple brain networks can thus improve clinical outcomes. Transcranial electrical stimulation (TES), a non-invasive brain stimulation technique, is a rapidly growing and promising intervention for cognitive dysfunctions, via altering the dysfunctional brain networks. In this study, we will explore three novel high definition transcranial infraslow random (grey, violet, and black) noise stimulation (HD-tIGNS, HD-tIVNS, HD- tIBNS) techniques, targeting the triple brain networks simultaneously (SN, CEN, DMN) in its anti-correlated pattern. We hypothesise that the HD-tIGNS technique will demonstrated greater positive effects on cognitive outcomes, when compared to other stimulation techniques. The outcomes of this study will help us to develop new brain stimulation treatments for people with cognitive disorders.
Interventions
High-definition transcranial electrical stimulation (TES) treatment targeting the anti-correlated activity of the triple brain networks [Salience network (SN), Default mode network (DMN), and Central Executive Network (CEN)] will be administered for four individual treatment sessions, each of 30 minutes duration, by the researcher experienced in administering neuromodulation techniques.
This study will be a double blinded (participant and assessor) pilot randomized placebo-controlled cross-ove
High-definition transcranial electrical stimulation (TES) treatment targeting the anti-correlated activity of the triple brain networks [Salience network (SN), Default mode network (DMN), and Central Executive Network (CEN)] will be administered for four individual treatment sessions, each of 30 minutes duration, by the researcher experienced in administering neuromodulation techniques. This study will be a double blinded (participant and assessor) pilot randomized placebo-controlled cross-over trial with one-week of washouts in between the four treatments [High definition transcranial infraslow grey noise stimulation (HD-tIGNS), High definition transcranial infraslow black noise stimulation (HD-tIBNS), High definition transcranial infraslow violet noise stimulation (HD-tIVNS), and Acti-sham stimulation]. Each of the four interventions will be administered for a single session of 30 minutes (i.e., each participant will attend only 4 treatment sessions in total; with one of the four treatments administered at each session in a randomised order). A battery-driven wireless 32 channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain, http://www.neuroelectrics.com) will be used to deliver stimulation while the participants are comfortably and quietly seated. The Starstim32 is a high definition system with small electrode size that can focally target deeper brain regions. Forty circular Ag/AgCl stimulation electrodes will be placed on a neoprene head cap following the International 10-20 EEG system. For the active stimulation phases (HD-tIGNS, HD-tIBNS, and HD-tIVNS), 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 the end of each stimulation session, with continuous stimulation in between. The montage of stimulating electrodes for the active stimulation phase will be C1, CP3, CP4, F5, F8, FC1, FC3, FP2, P3, P7, and T7. All the conditions for the three active treatment arms will remain same, except that a different stimulation waveform (HD-tIGNS, HD-tIBNS, and HD-tIVNS) will be used based on the treatment arm. Adherence of the intervention will be monitored using session attendance checklist.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Healthy volunteers
Yes
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 • Cognitively healthy, as determined by age norms of Mini Mental Status Examination • Age between 35 to 75 years on the day of the consent and • Right dominant
Exclusion criteria
Participants who meet any of the following conditions will be excluded: • History of neurological disease • History of epileptic seizures • Unstable medical or psychiatric conditions • Presence of any pacemaker or defibrillator • Presence of any implant in head/neck • Alcohol or substance abuse • History of any peripheral neuropathy or vascular pathology • Currently taking any anti-epileptic medications
Outcome results
None listed