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Effects of Neurofeedback in Cognitive Deficit in Patients With TBI

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ClinicalTrials.gov Identifier: NCT03515317
Recruitment Status : Not yet recruiting
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Hsiao-Yean Chiu, Taipei Medical University

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: LoRETA Z-score NF Behavioral: theta/beta NF Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Changes in Cognitive Functions in Patients With Recovery Stage of Traumatic Brain Injury: Effects and Mechanism of Neurofeedback
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LoRETA Z-score NF group
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
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.

Experimental: theta/beta NF group
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
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.

No Intervention: control group
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).



Primary Outcome Measures :
  1. The changes of cognitive functions about the sustained and selective aspects of visual attention. [ Time Frame: Measurement time points are pre-treatment (one week before the first treatment), posttreatment (one week after the last treatment), as well as at the 3rd and 6th month after the completion of treatment. ]
    The cognitive functions of the sustained and selective aspects of visual attention assessed by Ruff 2 & 7 Selection Attention Test.

  2. The changes of cognitive functions about the visual memory function. [ Time Frame: Measurement time points are pre-treatment (one week before the first treatment), posttreatment (one week after the last treatment), as well as at the 3rd and 6th month after the completion of treatment. ]
    The cognitive functions of visual memory function assessed by Rey Complex Figure Test.

  3. The changes of cognitive functions about verbal memory. [ Time Frame: Measurement time points are pre-treatment (one week before the first treatment), posttreatment (one week after the last treatment), as well as at the 3rd and 6th month after the completion of treatment. ]
    The cognitive functions of verbal memory assessed by Rey Auditory Verbal Learning Test.

  4. The changes of cognitive functions about information processing speed. [ Time Frame: Measurement time points are pre-treatment (one week before the first treatment), posttreatment (one week after the last treatment), as well as at the 3rd and 6th month after the completion of treatment. ]
    The cognitive functions of information processing speed assessed by Symbol Digit Modalities Test.


Secondary Outcome Measures :
  1. Return to productive activity [ Time Frame: Measurement time points are pre-treatment (one week before the first treatment), posttreatment (one week after the last treatment), as well as at the 3rd and 6th month after the completion of treatment. ]
    Using the Community integration questionnaire(CIQ).

  2. Quality of life [ Time Frame: Measurement time points are pre-treatment (one week before the first treatment), posttreatment (one week after the last treatment), as well as at the 3rd and 6th month after the completion of treatment. ]
    Evaluated by the quality of life after brain injury (QOLIBRI).

  3. Electroencephalography waves [ Time Frame: Measurement time points are pre-treatment (one week before the first treatment), posttreatment (one week after the last treatment), as well as at the 3rd and 6th month after the completion of treatment. ]
    Using the BrainMaster Discovery 24E with Neuroguide software.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 20 to 65 years, with a diagnosis of TBI at least 6 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515317


Contacts
Contact: Hsiao-Yean Chiu, PhD +886-2-27361661 ext 6329 hychiu0315@tmu.edu.tw

Sponsors and Collaborators
Taipei Medical University

Responsible Party: Hsiao-Yean Chiu, Assistant Professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT03515317     History of Changes
Other Study ID Numbers: N201704027
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hsiao-Yean Chiu, Taipei Medical University:
Cognitive impairments
Low Resolution tomography
Neurofeedback
Traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries