Traumatic Brain InjuryNCT03515317
Effects of Neurofeedback in Cognitive Deficit in Patients With TBI
A study testing LoRETA Z-score NF and theta/beta NF in people with Traumatic Brain Injury, run by Taipei Medical University at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- LoRETA Z-score NF and theta/beta NF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 4 sitesTaiwan
- Study dates
- 22 Apr 2018to 11 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 20 to 65 years, with a diagnosis of TBI at least 3 months before enrollment(Chronic phase, with an initial Glasgow Coma Scale score of 3-15 (i.e., initially rated in the attention, memory, and information processing speed) by the participants or treating clinician, are able to communicate in Mandarin Chinese, and are able to complete cognitive tasks (having Rancho Los Amigos Scale score>9) will be eligible for inclusion in the study.
Who cannot join
- The exclusion criteria include premorbid diagnoses of seizures, sleep disorders, psychiatry diseases, substance abuse, and alcoholism. Individuals who are pregnant, in the menopausal transition, and with impairments in vision, hearing, or motor functions that are severe enough to preclude participation in the research will be excluded.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Taipei Medical University
Taipei, 110
Taipei Medical University Hospital.
Taipei
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
Taipei
Taipei Municipal Wanfang Hospital (managed by Taipei Medical University)
Taipei
About this study
Official title: Changes in Cognitive Functions in Patients With Recovery Stage of Traumatic Brain Injury: Effects and Mechanism of Neurofeedback
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.
Read the detailed description
Cognitive impairment is the most common and debilitating residual symptom of traumatic brain injury (TBI) at all levels of severity and the prevalence of cognitive impairments varies, depending on the severity of the head injury and the time since the injury. Such impairments substantially affect a person's ability to return to productive activity and health-related quality of life. Furthermore, disabilities related to cognitive impairments following TBI increase healthcare costs and economic burden. Memory, attention, and information processing speed are basic cognitive functions. Deficits in such functions subsequently exacerbate disturbances in more complex cognitive functions (e.g., executive function). Therefore, targeting basic cognitive functions is the first priority of clinical treatments for post-traumatic cognitive impairments.
Cognitive rehabilitation, a nonpharmacological intervention, is the first-line treatment for the management of cognitive impairments following TBI. However, the findings of previous reviews are still debated, with one metaanalysis supporting its beneficial effects on attention recovery and two metaanalyses denying the positive association between cognitive rehabilitation and cognitive recovery. Pharmacotherapies (e.g., methylphenidate) has been potentially used to accelerate cognitive recovery in patients with TBI. Nevertheless, recent systematic reviews failed to prove its effects on cognitive recovery. Moreover, adverse effects may contribute to the discontinuation of stimulant medication use.Taken together, current treatments are insufficient for managing post-traumatic cognitive impairments. Nurses, the first-line healthcare providers, should therefore seek and employ an alternative approach to deal with cognitive impairments following TBI.
Both abnormal network connectivity of the brain (e.g., low neural communication between different brain areas) and dysregulated electroencephalographs (EEGs, e.g., increases in alpha and theta, and decrease in beta) following brain damage have been strongly connected to deficits in memory, sustained attention, and information processing speed. Neurofeedback (NF) can target and alter dysregulated brain functioning by giving real-time feedback of EEG activity to patients. Existing literatures have shown that NF might improve attention performance after TBI. Nonetheless, the effects of NF on other cognitive functions, such as memory and speed of information processing, have not been ascertained. In addition, limited methodological features of previous studies, including single group, pre- and posttreatment study design, small number of participants, and inconsistent treatment protocols, restrict their generalizability and practicability. Most importantly, knowledge regarding cognitive improvements being concomitant with changes in EEGs and the long-term effects of NF on cognitive recovery following TBI is still lacking.
- Conditions
- Traumatic Brain Injury
- Being tested
- LoRETA Z-score NF, theta/beta NF
- Keywords
- Cognitive impairments, Low Resolution tomography, Neurofeedback, Traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoRETA Z-score NFBehavioural
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.
theta/beta NFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Visual memory function
The cognitive functions of visual memory function assessed by Rey Complex Figure Test.
Measured: Three months
Verbal memory
The cognitive functions of verbal memory assessed by Rey Auditory Verbal Learning Test.
Measured: Three months
Information processing speed.
The cognitive functions of information processing speed assessed by Symbol Digit Modalities Test.
Measured: Three months
Secondary outcomes (3)
Return to productive activity
The ability of return to productive measured by the Community integration Questionnaire-Revised (CIQ-R). It is an 18-item ordinal scale designed to assess a person's integration into home and family life, social activity, and productive activity. The home integration, social integration, productivity integration, and electronic social networking subscales have 5, 6, 4, and 3 items, respectively, and each item is scored on a scale of 0 to 2. Higher scores reflect increasing levels of independence.
Measured: Three months
Health related quality of life
The general well-being of individuals and societies, outlining negative and positive features of life, which was evaluated by the quality of life after brain injury (QOLIBRI).The QOLIBRI consists of 37 items covering the following six dimensions of quality of life after TBI: cognition (7 items), self (7 items), daily life and autonomy (7 items), social relationships 6 items), emotions (5 items), and physical problems (5 items). It is scored by a five-point Likert scale with a higher score indicating better quality of life.
Measured: Three months
Electroencephalography waves
Using the BrainMaster Discovery 24E with Neuroguide software.
Measured: Three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start22 Apr 2018
- Primary completion10 Nov 2021
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515317
- Sponsor's protocol ID
- N201704027
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2018
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37125901
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cognitive Functions in Patients With Recovery Stage of Traumatic Brain Injury: Effects and Mechanism of Neurofeedback
- ClinicalTrials.gov ID
- NCT03515317
- Acronym / sponsor ID
- N201704027
- Conditions
- Traumatic Brain Injury
- Keywords
- Cognitive impairments, Low Resolution tomography, Neurofeedback, Traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 22 Apr 2018 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cognitive impairment is the most common and debilitating residual symptom of traumatic brain injury (TBI) at all levels of severity and the prevalence of cognitive impairments varies, depending on the severity of the head injury and the time since the injury. Such impairments substantially affect a person's ability to return to productive activity and health-related quality of life. Furthermore, disabilities related to cognitive impairments following TBI increase healthcare costs and economic burden. Memory, attention, and information processing speed are basic cognitive functions. Deficits in such functions subsequently exacerbate disturbances in more complex cognitive functions (e.g., executive function). Therefore, targeting basic cognitive functions is the first priority of clinical treatments for post-traumatic cognitive impairments.
Cognitive rehabilitation, a nonpharmacological intervention, is the first-line treatment for the management of cognitive impairments following TBI. However, the findings of previous reviews are still debated, with one metaanalysis supporting its beneficial effects on attention recovery and two metaanalyses denying the positive association between cognitive rehabilitation and cognitive recovery. Pharmacotherapies (e.g., methylphenidate) has been potentially used to accelerate cognitive recovery in patients with TBI. Nevertheless, recent systematic reviews failed to prove its effects on cognitive recovery. Moreover, adverse effects may contribute to the discontinuation of stimulant medication use.Taken together, current treatments are insufficient for managing post-traumatic cognitive impairments. Nurses, the first-line healthcare providers, should therefore seek and employ an alternative approach to deal with cognitive impairments following TBI.
Both abnormal network connectivity of the brain (e.g., low neural communication between different brain areas) and dysregulated electroencephalographs (EEGs, e.g., increases in alpha and theta, and decrease in beta) following brain damage have been strongly connected to deficits in memory, sustained attention, and information processing speed. Neurofeedback (NF) can target and alter dysregulated brain functioning by giving real-time feedback of EEG activity to patients. Existing literatures have shown that NF might improve attention performance after TBI. Nonetheless, the effects of NF on other cognitive functions, such as memory and speed of information processing, have not been ascertained. In addition, limited methodological features of previous studies, including single group, pre- and posttreatment study design, small number of participants, and inconsistent treatment protocols, restrict their generalizability and practicability. Most importantly, knowledge regarding cognitive improvements being concomitant with changes in EEGs and the long-term effects of NF on cognitive recovery following TBI is still lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LoRETA Z-score NF group | Experimental | Behavioral: LoRETA Z-score NFBrainMaster 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. |
| theta/beta NF group | Experimental | Behavioral: theta/beta NFBrainMaster 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. |
| 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). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 20 to 65 years, with a diagnosis of TBI at least 3 months before enrollment(Chronic phase, with an initial Glasgow Coma Scale score of 3-15 (i.e., initially rated in the attention, memory, and information processing speed) by the participants or treating clinician, are able to communicate in Mandarin Chinese, and are able to complete cognitive tasks (having Rancho Los Amigos Scale score>9) will be eligible for inclusion in the study.
Key exclusion criteria (1 listed)
- The exclusion criteria include premorbid diagnoses of seizures, sleep disorders, psychiatry diseases, substance abuse, and alcoholism. Individuals who are pregnant, in the menopausal transition, and with impairments in vision, hearing, or motor functions that are severe enough to preclude participation in the research will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoRETA Z-score NFLoRETA 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. | Behavioural | LoRETA Z-score NF group |
| theta/beta NFThe 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. | Behavioural | theta/beta NF group |
Primary outcome
Sustained and selective aspects of visual attention.
Time frame: three months
The cognitive functions of the sustained and selective aspects of visual attention assessed by Ruff 2 \& 7 Selection Attention Test.
Visual memory function
Time frame: Three months
The cognitive functions of visual memory function assessed by Rey Complex Figure Test.
Verbal memory
Time frame: Three months
The cognitive functions of verbal memory assessed by Rey Auditory Verbal Learning Test.
Information processing speed.
Time frame: Three months
The cognitive functions of information processing speed assessed by Symbol Digit Modalities Test.
3 secondary outcomes
Return to productive activity
Time frame: Three months
Health related quality of life
Time frame: Three months
Electroencephalography waves
Time frame: Three month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 37125901Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoRETA Z-score NF and theta/beta NF in people with Traumatic Brain Injury, run by Taipei Medical University at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained and selective aspects of visual attention. (time frame: three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.