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Recruiting NCT05834920

Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention

No phase Interventional Attention Difficulties

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial pulse stimulation (TPS), Neurofeedback.
Who it may be relevant to
Registry conditions: Attention Difficulties. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Device Transcranial pulse stimulation (TPS)
    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.
  • Device 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.

Primary outcome measures

  • Change from baseline in Conners' Continuous Performance Test 3rd Edition [Time frame: 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]
Secondary outcome measures (9)
  • Change from baseline in Stroop task [Time frame: 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]
  • Change from baseline in Goal Orientation Scale [Time frame: Baseline, week 4, week 8, week 12, week 16]
  • Change from baseline in N-back task [Time frame: 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]
  • Change from baseline in Attentional Control Scale [Time frame: 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]
  • Change from baseline in Social Connectedness Scale [Time frame: Baseline, week 4, week 8, week 12, week 16]
  • Change from baseline in Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline, week 4, week 8, week 12, week 16]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • HKU InnoCentre of Clinical Neuropsychology — Hong Kong

Identifiers

NCT: NCT05834920 · HKUNFBTPS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗