Investigating the Effectiveness of a 2-week Novel Non-invasive Brain Stimulation Technique on Cognitive Outcomes in Healthy Adults

NCT ID: NCT06991764

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-04-30

Brief Summary

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The goal of this randomised controlled trial is to investigate the effects of a 2-week high-frequency transcranial pulsed current stimulation (tPCS) on cognitive outcomes in older and healthy adults. The main questions it aims to answer are:

1. Would a single session of anodal tPCS over the left prefrontal cortex improve working memory, task inhibition, and task switching in healthy young and older adults, compared to anodal transcranial direct current stimulation (tDCS) and sham-tPCS?
2. Would repeated session of anodal-tPCS (2-weeks) lead to improvements in working memory, task inhibition, and task switching in healthy young and older adults, compared to tDCS and sham-tPCS?
3. Will tPCS be better tolerated among healthy adults, compared to tDCS?

Researchers will compare tPCS / tDCS / sham-tPCS to see if there are any differences in cognitive outcomes after 1 session and after repeated sessions, as well as to compare the tolerance of tPCS against tDCS and sham-tPCS.

Participants will be requested to:

* Undergo 1 of 3 of the following conditions: tDCS / tPCS / sham-tPCS
* Complete three sessions of cognitive tasks testing working memory, inhibition and task switching at baseline (pre-stimulation), after day 1 of brain stimulation and after 10 sessions of brain stimulation (post- repeated stimulation)
* Undergo fNIRS-EEG brain measurements concurrently with the cognitive tasks

Detailed Description

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tPCS / tDCS and sham-tPCS will be administered between 0.6 to 0.7 mA for 20 minutes. This will take place over 10 consecutive sessions, with a 2 day break between days 5 and 6 of brain stimulation. The setup of the stimulation consists of a saline-soaked sponge anode electrode placed over the left forehead area over the left dorsal lateral prefrontal cortex, and the cathode will be placed over the right parietal cortex. Participants will be randomly assigned to 1 of 3 conditions and this will be blinded to both the participants and the researcher (double-blinded).

Cognitive tasks will be administered at baseline, after 1 session of stimulation and after 10 sessions of stimulation (post-stimulation). These cognitive tasks consist of a working memory task (1/2/3 back tasks), a cognitive inhibition task (go/no-go task) and a cognitive flexibility task (Stroop task). Concurrent with the cognitive task will be the administration of fNIRS-EEG recording to measure changes in brain activation and patterns during the tasks.

The experiment will take place in the Motor Behaviour Lab at the National Institute of Education, Nanyang Technological University in Singapore.

Conditions

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Transcranial Direct Current Stimulation (tDCS) Ageing Executive Functioning Transcranial Electric Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to 1 of 3 conditions.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transcranial Direct Current Stimulation (tDCS)

In this condition, current intensity will be maintained between 0.6 to 0.7 mA for 20 minutes.

Group Type ACTIVE_COMPARATOR

Non-Invasive Brain Stimulation (tDCS / tPCS / sham-tPCS)

Intervention Type DEVICE

This is a novel non-invasive brain stimulation technique that we hope to be investigating, and this technique will be compared with an active control (tDCS) and a control (sham-tPCS).

High Frequency Transcranial Pulsed Current Stimulation (HF-tPCS)

In this condition, current will be introduced in pulses with intensity consistent between 0.6 to 0.7 mA. The duration of the stimulation is 20 minutes.

Group Type EXPERIMENTAL

Non-Invasive Brain Stimulation (tDCS / tPCS / sham-tPCS)

Intervention Type DEVICE

This is a novel non-invasive brain stimulation technique that we hope to be investigating, and this technique will be compared with an active control (tDCS) and a control (sham-tPCS).

Sham-tPCS

In this condition, there will be a 30 seconds ramp-up phase to a current intensity between 0.6 to 0.7 mA followed by a 30 seconds ramp-down phase to 0 mA. The participant will, however, remain seated with the set-up for the remaining time until 20 minutes is up.

Group Type SHAM_COMPARATOR

Non-Invasive Brain Stimulation (tDCS / tPCS / sham-tPCS)

Intervention Type DEVICE

This is a novel non-invasive brain stimulation technique that we hope to be investigating, and this technique will be compared with an active control (tDCS) and a control (sham-tPCS).

Interventions

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Non-Invasive Brain Stimulation (tDCS / tPCS / sham-tPCS)

This is a novel non-invasive brain stimulation technique that we hope to be investigating, and this technique will be compared with an active control (tDCS) and a control (sham-tPCS).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male and female young (21 to 30 years) and older adults (60 to 75 years)
* Right-handed
* Must be a native English speaker
* No clinical diagnosis of neurodevelopmental, mood, neurological or neurodegenerative disorders
* Adults with cardiometabolic or cardiovascular conditions may participate if their condition is controlled and stable with medication and / or lifestyle interventions

Exclusion Criteria

* Currently on long-term medication for pain or migraines / headaches
* Adults with metallic implants in the chest or head region
* Adults with epilepsy, or known seizure or immediate family members that have had a seizure before
* Had a recent head injury that resulted in a temporary loss of consciousness or of memory in the last 12 months
* Had prior head surgery
* Prone to fainting
* Sensitive skin or prone to skin allergies
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Education, Singapore

OTHER_GOV

Sponsor Role collaborator

National Institute of Education, Singapore

OTHER

Sponsor Role collaborator

Nanyang Technological University

OTHER

Sponsor Role lead

Responsible Party

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Teo Wei Peng

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Peng Teo, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

National Institute of Education, Nanyang Technological University, Singapore

Central Contacts

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Wei Peng Teo, Associate Professor

Role: CONTACT

(+65)67903704

Shun Xin Koong

Role: CONTACT

(+65)83078316

Other Identifiers

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IRB-2025-003

Identifier Type: -

Identifier Source: org_study_id

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