Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorThe University of Hong Kong

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 20 years and above

Right-handed

Normal/corrected hearing and vision

Having basic literacy skills

Disqualifiers

Having medical history related to brain

Having mild cognitive impairment

Showing symptoms of depression and anxiety

Having intellectual disability based on IQ scores

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Neurofeedback

    Device

    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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: NeurofeedbackActive comparator 1 intervention
Group B: Transcranial pulse stimulationExperimental treatment 1 intervention
Group C: WaitlistNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, week 4, week 8, week 12, week 16
2

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.

Time frame
Baseline, week 4, week 8, week 12, week 16

Secondary outcomes

1

Change from baseline in Stroop task

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
2

Change from baseline in General Health Questionnaire

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
3

Change from baseline in Goal Orientation Scale

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
4

Change from baseline in N-back task

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

Other outcomes

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