Mild Cognitive Impairment Clinical Trial
Official title:
Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Improve Concentration and Working Memory in Active Duty Service Members Following Mild Traumatic Brain Injury (mTBI): A Pilot Study
The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - (1) Have a remote history mild traumatic brain injury as defined by the VA/DoD clinical practice guidelines(The Management of Concussion/mTBI Working Group, 2016) that is >/= 6 months, and report moderate severity neurocognitive symptoms related to attention, concentration, working memory, or memory based on NSI scores and self-report. - (2) Are between the ages of 18-55. - (3) Are stable on any medications for at least 2 weeks at the baseline visit (Visit #1). Exclusion Criteria: - (1) Have a history of seizures or epilepsy. - (2) Have a history of ECT or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies. - (3) Have current stimulant dependence. - (4) Have a diagnosis of intellectual disability or pervasive developmental disorder (i.e. premorbid IQ less than or equal to 70). - (5) Have any medical condition or treatment other than mild TBI (e.g. stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgement, would impact risk. - (6) Diagnosed with current active psychosis or mania. - (7) Have metallic cranial plates/screws or implanted device, - (8) Have eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation. - (9) Pregnant individuals and individuals with ferromagnetic metal in their body that would prohibit them from being safe in the MRI will not be excluded from the overall study, but will be excluded from the optional MRI. |
Country | Name | City | State |
---|---|---|---|
United States | Naval Medical Center San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
United States Naval Medical Center, San Diego | The Defense and Veterans Brain Injury Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symbol Digit Modalities Test (SDMT) | Standardized neuropsychological assessment measure of visual attention and working memory | Change from Baseline SDMT at 1 week after the intervention. | |
Primary | Symbol Digit Modalities Test (SDMT) | Standardized neuropsychological assessment measure of visual attention and working memory | Change from Baseline SDMT at 6 weeks after the intervention. | |
Primary | Symbol Digit Modalities Test (SDMT) | Standardized neuropsychological assessment measure of visual attention and working memory | Change from 1 week post-intervention SDMT at 6 weeks after the intervention. | |
Primary | Neuropsychological Assessment Battery (NAB) Attention Module | Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning. | Change from Baseline NAB Attention Module at 1 week after the intervention. | |
Primary | Neuropsychological Assessment Battery (NAB) Attention Module | Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning. | Change from Baseline NAB Attention Module at 6 weeks after the intervention. | |
Primary | Neuropsychological Assessment Battery (NAB) Attention Module | Standardized neuropsychological assessment consisting of 4 subtests to assess visual and auditory attention, working memory, and scanning. | Change from 1 week post-intervention NAB Attention Module at 6 weeks after the intervention. | |
Primary | Electroencephalogram (EEG) | EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. | Change from Baseline EEG at 1 week after the intervention. | |
Primary | Electroencephalogram (EEG) | EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. | Change from Baseline EEG at 6 weeks after the intervention. | |
Primary | Electroencephalogram (EEG) | EEG will be collected to assess neural dynamics during rest and during performance of generalization tasks. The neural dynamics to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. | Change from 1 week post-intervention EEG at 6 weeks after the intervention. | |
Primary | Neurobehavioral Symptom Inventory (NSI) | A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms. | Change from Baseline NSI at 1 week after the intervention. | |
Primary | Neurobehavioral Symptom Inventory (NSI) | A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms. | Change from Baseline NSI at 6 weeks after the intervention. | |
Primary | Neurobehavioral Symptom Inventory (NSI) | A measure of common post-concussive symptoms rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to more severe incidence of symptoms. | Change from 1 week post-intervention NSI at 6 weeks after the intervention. | |
Primary | Magnetic Resonance Imaging (MRI) w/out contrast (optional) | Medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body. Mean white matter and CSF signals across time are calculated for each participant. Additionally, time courses for regions of interest are also extracted. | Change from Baseline MRI at 1 week after the intervention. | |
Secondary | NIH Toolbox Quality of Life Assessment (NeuroQoL) | Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities. | Change from Baseline NeuroQoL at 1 week after the intervention. | |
Secondary | NIH Toolbox Quality of Life Assessment (NeuroQoL) | Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities. | Change from Baseline NeuroQoL at 6 weeks after the intervention. | |
Secondary | NIH Toolbox Quality of Life Assessment (NeuroQoL) | Questionnaire to assess quality of life with regard to cognitive, social, emotional, and behavioral abilities rated on a 5-point Likert scale (1-5); with low scores corresponding to mild to no impairment in these abilities and high scores corresponding to more severe impairment in these abilities. | Change from 1 week post-intervention NeuroQoL at 6 weeks after the intervention. | |
Secondary | Insomnia Severity Index (ISI) | Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia. | Change from Baseline ISI at 1 week after the intervention. | |
Secondary | Insomnia Severity Index (ISI) | Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia. | Change from Baseline ISI at 6 weeks after the intervention. | |
Secondary | Insomnia Severity Index (ISI) | Measure of insomnia severity rated on a 5-point Likert scale (0-4); with low scores corresponding to mild or no incidence of insomnia and high scores corresponding to more severe incidences of insomnia. | Change from 1 week post-intervention ISI at 6 weeks after the intervention. | |
Secondary | Fusion Task | Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score. | Change from Baseline Fusion task at 1 week after the intervention. | |
Secondary | Fusion Task | Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score. | Change from Baseline Fusion task at 6 weeks after the intervention. | |
Secondary | Fusion Task | Multi-modal assessment of brain function including EEG and eye tracking. The EEG measures to be assessed include functional connectivity, mean ERP amplitude, and spectral power of delta, theta, alpha, beta, and gamma frequency bands. Other outcome measures to be assessed include saccadic response time latency, saccadic response time consistency, manual response time latency, manual response time consistency, and 1-back total score. | Change from 1 week post-intervention Fusion task at 6 weeks after the intervention. | |
Secondary | tDCS Symptom Rating Questionnaire (SRQ) | Questionnaire to assess pre-post tDCS symptom rating, rated on a 4-point Likert scale (0-3); with low scores corresponding to mild or no incidence of symptoms and high scores corresponding to severe incidence of symptoms. | Change from pre-intervention SRQ at post-intervention. | |
Secondary | BrainHQ Task Load Index (TLX) | Subjective workload assessment of level of effort, mental demand, frustration, and performance during cognitive training, rated on a 10-point Likert scale (1-10); with low scores corresponding to less effort or mental demand and high scores corresponding to more effort or mental demand. | Immediately after the intervention. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04513106 -
Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial
|
N/A | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Active, not recruiting |
NCT03167840 -
Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment
|
N/A | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Not yet recruiting |
NCT05041790 -
A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment
|
Phase 4 | |
Recruiting |
NCT04121156 -
High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Completed |
NCT02774083 -
Cognitive Training Using Feuerstein Instrumental Enrichment
|
N/A | |
Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
Enrolling by invitation |
NCT06023446 -
Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
|
||
Completed |
NCT04567745 -
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
|
Phase 1 | |
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Terminated |
NCT02503501 -
Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease
|
Phase 2 | |
Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT02663531 -
Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Recruiting |
NCT03507192 -
Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
|
N/A |