- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834920
Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention
November 27, 2023 updated by: Maria Teresa Wijaya, The University of Hong Kong
The present study aims to examine and compare the effectiveness of transcranial pulse stimulation and neurofeedback among adults who are weak in attention.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maria T Wijaya, PhD
- Phone Number: (852) 3917-8927
- Email: mtwijaya@hku.hk
Study Locations
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-
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Hong Kong, Hong Kong
- Recruiting
- HKU InnoCentre of Clinical Neuropsychology
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Contact:
- Maria T Wijaya, PhD
- Phone Number: (852) 3917-8927
- Email: mtwijaya@hku.hk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged 20 years and above
- Right-handed
- Normal/corrected hearing and vision
- Having basic literacy skills
- Having sustained attention scores below the threshold
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Waitlist
|
|
Active Comparator: Neurofeedback
|
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.
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Experimental: Transcranial pulse stimulation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Conners' Continuous Performance Test 3rd Edition
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
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
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Stroop task
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
The Victoria version of the Stroop task is a validated means of measuring the ability to inhibit cognitive interference.
Over three tasks of increasing difficulty level, participants are asked to identify colors as they appear on stimulus flash cards.
These colors are randomly ordered either as dots, noncolor words, or noncorresponding color words.
Performance is measured by reaction times and accuracy.
Shorter reaction times and higher accuracy indicate better ability to inhibit cognitive interference.
|
Baseline, week 4, week 8, week 12, week 16
|
Change from baseline in General Health Questionnaire
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
The General Health Questionnaire (GHQ) measures psychological well-being.
It comprises 12 self-report questions, each assessing the severity of a mental problem over the past few weeks.
Total scores range from 0 to 36 with a higher score indicating poorer psychological states.
|
Baseline, week 4, week 8, week 12, week 16
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Change from baseline in Goal Orientation Scale
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
The Goal Orientation Scale measures how individuals interpret and respond to achievement situations.
It comprises three subscales.
The present study uses only the learning goal orientation subscale which consists of 5 self-report items measuring the desire to develop the self by acquiring new skills, mastering new situations, and improving one's competence.
Total scores range from 5 to 35 with higher scores indicating greater learning goal orientation.
|
Baseline, week 4, week 8, week 12, week 16
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Change from baseline in N-back task
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
The N-back task measures working memory function.
Participants are presented a sequence of numbers ranging from 0 to 9 one-by-one.
For each, they are required to decide whether the current stimulus is the same as the one presented two trials ago.
Performance is measured by reaction times and accuracy.
Shorter reaction times and higher accuracy indicate better working memory.
|
Baseline, week 4, week 8, week 12, week 16
|
Change from baseline in Color Trails Test
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
The Color Trails Test (CTT) is used to assess attention shifting (i.e., the ability to alternate attention between two goals) and processing speed (i.e., the speed with which a cognitive operation is carried out).
The test comprises two parts: CTT1 requires participants to connect a series of numbered circles that are randomly printed on a sheet of paper and CTT2 requires participants to connect numbered circles from 1 to 25 alternating between two colors (pink and yellow).
Performance is measured by reaction times with faster reaction times indicating better flexibility and speed.
|
Baseline, week 4, week 8, week 12, week 16
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Change from baseline in Attentional Control Scale
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
The Attentional Control Scale is a self-report measure of attentional control.
It consists of two subscales which measure selective attention and attention shifting respectively.
Total scores range from 20 to 80 with higher scores indicating better attentional control.
|
Baseline, week 4, week 8, week 12, week 16
|
Change from baseline in Rosenberg Self-esteem Scale
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
The Rosenberg Self-Esteem Scale is a 10-item self-report questionnaire which measures global self-esteem by measuring both positive and negative feeling about the self.
Scores range from 10 to 40 with higher scores reflecting higher self-esteem.
|
Baseline, week 4, week 8, week 12, week 16
|
Change from baseline in Social Connectedness Scale
Time Frame: Baseline, week 4, week 8, week 12, week 16
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The Social Connectedness Scale comprises 8 self-report items measuring three aspects of belongingness: connectedness, affiliation, and companionship.
Total scores range from 8 to 48 with higher scores indicating higher sense of social connectedness.
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Baseline, week 4, week 8, week 12, week 16
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Change from baseline in Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, week 4, week 8, week 12, week 16
|
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report questionnaire comprising two subscales which assess levels of anxiety and depression respectively.
Total scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety or depression.
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Baseline, week 4, week 8, week 12, week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 17, 2023
Primary Completion (Estimated)
November 15, 2024
Study Completion (Estimated)
November 15, 2024
Study Registration Dates
First Submitted
March 17, 2023
First Submitted That Met QC Criteria
April 17, 2023
First Posted (Actual)
April 28, 2023
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- HKUNFBTPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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