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

NCT06991764 | Not Yet Recruiting DMC

• 1 other identifier: IRB-2025-003
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• 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

Conditions

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

Keywords

Randomised Controlled Trial; Non-Invasive Brain Stimulation; Executive Functioning; Transcranial Direct Current Stimulation; Transcranial Pulsed Current Stimulation; Healthy Adults; Ageing

Outcome Measures

Primary Outcomes (3)

• Executive Functioning

  Working memory through 1-, 2- and 3-back tasks performance Behavioural inhibitory control through Go / No-Go task performance Cognitive flexibility through Stroop task performance

  Baseline, after day 1 of stimulation, 3 to 4 days after the 10 sessions of stimulation

• Task-based activation and functional connectivity during executive functioning tasks

  Measuring changes in hemodynamic (oxyhaemoglobin) responses in the brain using Functional Near-Infrared Spectroscopy (fNIRS)

  Baseline, after day 1 of stimulation, 3 to 4 days after the 10 sessions of stimulation

• Neural function associated with executive functioning tasks

  Measuring neural activity using electroencephaogram (EEG) whereby traditional EEG bands (e.g. Alpha, Beta, Theta, Delta) will be assessed.

  Baseline, after day 1 of stimulation, 3 to 4 days after the 10 sessions of stimulation

Secondary Outcomes (1)

• Tolerance of tPCS (intervention)

  Immediately after the intervention

Study Arms (3)

Transcranial Direct Current Stimulation (tDCS)

ACTIVE COMPARATOR

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

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

High Frequency Transcranial Pulsed Current Stimulation (HF-tPCS)

EXPERIMENTAL

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.

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

Sham-tPCS

SHAM COMPARATOR

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.

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

Interventions

Non-Invasive Brain Stimulation (tDCS / tPCS / sham-tPCS) 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); Sham-tPCS; Transcranial Direct Current Stimulation (tDCS)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanyang Technological University: lead
• Ministry of Education, Singapore: collaborator
• National Institute of Education, Singapore: collaborator

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wei Peng Teo, Associate Professor

  National Institute of Education, Nanyang Technological University, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Peng Teo, Associate Professor

CONTACT

(+65)67903704; weipeng.teo@nie.edu.sg

Shun Xin Koong

CONTACT

(+65)83078316; nie25.ksx@e.ntu.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to 1 of 3 conditions.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 28, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share