NCT03515317

Brief Summary

Background: Cognitive impairment is common in patients with traumatic brain injury (TBI) at all levels of severity. Such impairments may affect their ability to return to work and thus increase healthcare costs and the associated economic burdens. Both cognitive rehabilitation and stimulant medications are widely used to manage post-traumatic cognitive impairments; however, previous metaanalyses failed to demonstrate their beneficial effects on cognitive recovery in patients with TBI. Nurses, the first-line healthcare providers, should therefore seek and use an alternative approach for dealing with post-traumatic cognitive deficits. Purpose: To assess the effects of low resolution tomography (LoRETA) Z -score neurofeedback (NF) and theta/beta NF in alleviating cognitive impairments in patients with TBI as well as the possible mechanism through which they provide this alleviation. We hypothesize that adults with TBI receiving LoRETA Z-score NF and theta/beta NF will experience the improvements in cognitive functions while participants in the control group will not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 22, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

3.6 years

First QC Date

March 18, 2018

Last Update Submit

April 18, 2024

Conditions

Traumatic Brain Injury

Keywords

Cognitive impairmentsLow Resolution tomographyNeurofeedbackTraumatic brain injury

Outcome Measures

Primary Outcomes (4)

  • Sustained and selective aspects of visual attention.

    The cognitive functions of the sustained and selective aspects of visual attention assessed by Ruff 2 \& 7 Selection Attention Test.

    three months

  • Visual memory function

    The cognitive functions of visual memory function assessed by Rey Complex Figure Test.

    Three months

  • Verbal memory

    The cognitive functions of verbal memory assessed by Rey Auditory Verbal Learning Test.

    Three months

  • Information processing speed.

    The cognitive functions of information processing speed assessed by Symbol Digit Modalities Test.

    Three months

Secondary Outcomes (3)

  • Return to productive activity

    Three months

  • Health related quality of life

    Three months

  • Electroencephalography waves

    Three month

Study Arms (3)

LoRETA Z-score NF group

EXPERIMENTAL

BrainMaster Discovery 24E (BrainMaster Technologies, Inc.) combined with Neuroguide software (Applied Neuroscience, Inc.) to conduct both LoRETA Z-score NF. A total treatment dosage of 600 minutes is needed.

Behavioral: LoRETA Z-score NF

theta/beta NF group

EXPERIMENTAL

BrainMaster Discovery 24E (BrainMaster Technologies, Inc.) combined with Neuroguide software (Applied Neuroscience, Inc.) to conduct both theta/beta NF. A total treatment dosage of 600 minutes is needed.

Behavioral: theta/beta NF

control group

NO INTERVENTION

The control group involves no NF training. The control group will be designed to parallel the cognitive tasks to control for practice effects due to repeated testing (pre- and post- assessments) and the time effect on cognitive function recovery (spontaneous recovery of cognition).

Interventions

LoRETA Z-score NFBEHAVIORAL

LoRETA Z-score NF will be conducted using a 19-lead cap (Electrocap, Inc), which will be placed on the head according to the standard approach of the international 10-20 system with linked ear and ground reference. After the caps will be less than 5 kΩ. During each session, the participants will sit in front of a computer screen on which predesigned games or animations related to the LoRETA Z-score training are played and instructions regarding the inhibitory and reward aspects of the training are taught.

LoRETA Z-score NF group
theta/beta NFBEHAVIORAL

The goal of theta/beta NF is to increase the beta power(13-20 Hz) and simultaneously inhibit the theta power (4-8 Hz) relative to a baseline assessed at the beginning of a training session. The electrodes will be placed on Fz and Cz with a linked ear model(A1). The study will use both visual and auditory feedback. Each participant will sit in front of a computer screen on which predesigned games or animations related to the training criteria are played and instructions regarding the inhibitory and reward aspects of the training are taught. The threshold will be set according to 5-min baseline EEG measurements before each session. The thresholds are the mean amplitude of the beta and the theta in 5-min baseline EEG.

theta/beta NF group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Taipei Medical University

Taipei, 110, Taiwan

Location

Taipei Medical University Hospital.

Taipei, Taiwan

Location

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Taipei, Taiwan

Location

Taipei Municipal Wanfang Hospital (managed by Taipei Medical University)

Taipei, Taiwan

Location

Related Publications (1)

  • Chen PY, Su IC, Shih CY, Liu YC, Su YK, Wei L, Luh HT, Huang HC, Tsai PS, Fan YC, Chiu HY. Effects of Neurofeedback on Cognitive Function, Productive Activity, and Quality of Life in Patients With Traumatic Brain Injury: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2023 May;37(5):277-287. doi: 10.1177/15459683231170539. Epub 2023 Apr 26.

    PMID: 37125901DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCognition DisordersNeurocognitive DisordersMental Disorders

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
Associate Professor

Study Record Dates

First Submitted

March 18, 2018

First Posted

May 3, 2018

Study Start

April 22, 2018

Primary Completion

November 10, 2021

Study Completion

May 11, 2022

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations

TW(4)