Back to resultsEffects of Neurofeedback and Transcranial Pulse Stimulation on Attention
Primary Purpose
Attention Difficulties
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transcranial pulse stimulation (TPS)
Neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Attention Difficulties
Eligibility Criteria
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
Sites / Locations
- HKU InnoCentre of Clinical NeuropsychologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
Neurofeedback
Transcranial pulse stimulation
Waitlist
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in Conners' Continuous Performance Test 3rd Edition
1. 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.
Change from baseline in gradCPT continuous performance test
2. 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.
Secondary Outcome Measures
Change from baseline in Stroop task
3. 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.
Change from baseline in General Health Questionnaire
4. 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.
Change from baseline in Goal Orientation Scale
5. 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.
Change from baseline in N-back task
6. 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.
Change from baseline in Color Trails Test
7. 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.
Change from baseline in Attentional Control Scale
8. 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.
Change from baseline in Rosenberg Self-esteem Scale
9. 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.
Change from baseline in Social Connectedness Scale
10. 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.
Change from baseline in Hospital Anxiety and Depression Scale (HADS)
11. 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.
Full Information
NCT ID
NCT05834920
First Posted
March 17, 2023
Last Updated
April 17, 2023
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05834920
Brief Title
Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention
Official Title
Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Difficulties
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback
Arm Type
Active Comparator
Arm Title
Transcranial pulse stimulation
Arm Type
Experimental
Arm Title
Waitlist
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Transcranial pulse stimulation (TPS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Conners' Continuous Performance Test 3rd Edition
Description
1. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Title
Change from baseline in gradCPT continuous performance test
Description
2. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Secondary Outcome Measure Information:
Title
Change from baseline in Stroop task
Description
3. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Title
Change from baseline in General Health Questionnaire
Description
4. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Title
Change from baseline in Goal Orientation Scale
Description
5. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Title
Change from baseline in N-back task
Description
6. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Title
Change from baseline in Color Trails Test
Description
7. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Title
Change from baseline in Attentional Control Scale
Description
8. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Title
Change from baseline in Rosenberg Self-esteem Scale
Description
9. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Title
Change from baseline in Social Connectedness Scale
Description
10. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
Title
Change from baseline in Hospital Anxiety and Depression Scale (HADS)
Description
11. 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.
Time Frame
Baseline, week 4, week 8, week 12, week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria T Wijaya, PhD
Phone
(852) 3917-8927
Email
mtwijaya@hku.hk
Facility Information:
Facility Name
HKU InnoCentre of Clinical Neuropsychology
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria T Wijaya, PhD
Phone
(852) 3917-8927
Email
mtwijaya@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention
We'll reach out to this number within 24 hrs