NCT05834920

Brief Summary

The present study aims to examine and compare the effectiveness of transcranial pulse stimulation and neurofeedback among adults who are weak in attention.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

March 17, 2023

Last Update Submit

February 28, 2025

Conditions

Attention Difficulties

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Conners' Continuous Performance Test 3rd Edition

    The Conners' Continuous Performance Test (CPT) measures inattentiveness, impulsivity, sustained attention, and vigilance. Participants are required to push the spacebar when any letter, except "X", appears. Performances are measured in raw scores and standardized T scores. T scores between 45-54 indicate average performance, higher or lower scores indicate atypical performance.

    Baseline, week 4, week 8, week 12, week 16

  • Change from baseline in gradCPT continuous performance test

    The GradCPT is a continuous performance test to measure sustained attention. It has been shown to reliably indicate attentional fluctuation over time. Participants are required to respond to frequently presented city scene and inhibit responses to infrequently presented mountain scene. The sequence of visual stimuli is presented with gradual transitions to minimize involuntary attention capture by abrupt stimulus onset and offset. The main outcome of interest is reaction times variability, with higher variability indicating poorer sustained attention.

    Baseline, week 4, week 8, week 12, week 16

Secondary Outcomes (9)

  • Change from baseline in Stroop task

    Baseline, week 4, week 8, week 12, week 16

  • Change from baseline in General Health Questionnaire

    Baseline, week 4, week 8, week 12, week 16

  • Change from baseline in Goal Orientation Scale

    Baseline, week 4, week 8, week 12, week 16

  • Change from baseline in N-back task

    Baseline, week 4, week 8, week 12, week 16

  • Change from baseline in Color Trails Test

    Baseline, week 4, week 8, week 12, week 16

  • +4 more secondary outcomes

Study Arms (3)

Neurofeedback

ACTIVE COMPARATOR
Device: Neurofeedback

Transcranial pulse stimulation

EXPERIMENTAL
Device: Transcranial pulse stimulation (TPS)

Waitlist

NO INTERVENTION

Interventions

Transcranial pulse stimulation (TPS)DEVICE

Participants will be treated with the TPS device NEUROLITH (Storz Medical AG). Treatments will be administered for up to 12 sessions within 4 weeks, each session consisting of 6000 TPS pulses of 0.2 mJ/mm².

Transcranial pulse stimulation
NeurofeedbackDEVICE

Participants will engage in a neurofeedback game designed to increase the ratio of theta/beta frequency bands in electroencephalography measurement. This intervention will be delivered for up to 12 sessions within 4 weeks.

Neurofeedback

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20 years and above
  • Right-handed
  • Normal/corrected hearing and vision
  • Having basic literacy skills
  • Having sustained attention scores below the threshold

You may not qualify if:

  • Having medical history related to brain
  • Having mild cognitive impairment
  • Showing symptoms of depression and anxiety
  • Having intellectual disability based on IQ scores
  • Having diagnoses of any psychiatric or cognitive disorders besides attention deficit hyperactivity disorder (ADHD) inattentive and combined types
  • Having long-term history of smoking cigarettes
  • Engaged in alcohol and/or substance abuse
  • Having history of hemophilia or other blood clotting disorders or thrombosis
  • Having corticosteroid treatment within the last six weeks before first intervention
  • Having contraindications for MRI scanning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HKU InnoCentre of Clinical Neuropsychology

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic StimulationNeurofeedback

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsBiofeedback, PsychologyMind-Body TherapiesComplementary TherapiesBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Central Study Contacts

Maria T Wijaya, PhD

CONTACT

(852) 3917-8927mtwijaya@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral Fellow

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 28, 2023

Study Start

March 17, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)