Cognitive Rehabilitation for Stroke-Related Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Developmental disability, Psychiatric disorder, Substance abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP).
Both CICT and BF-HELP will involve 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program.
The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis.
Participants will be randomly assigned to the interventions.
Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Cognitive Transfer Package and related therapies for stroke-related cognitive impairment?
Research shows that computerized cognitive training can improve cognitive functions in stroke patients, and Speed of Processing Training (SOPT) has been effective in improving everyday functional outcomes in people with multiple sclerosis, suggesting potential benefits for stroke-related cognitive impairment.
12345Is cognitive rehabilitation therapy safe for stroke patients?
Research shows that cognitive rehabilitation therapy, including combined aerobic, resistance, and cognitive training, is generally safe for stroke patients. In a study with 131 participants, no serious adverse events related to the intervention were reported.
15678How is Speed of Processing Training (SOPT) different from other treatments for stroke-related cognitive impairment?
Speed of Processing Training (SOPT) is unique because it focuses on enhancing the brain's ability to process information quickly, often using computer-based exercises, which is different from traditional therapies that may not specifically target processing speed. This approach can lead to improvements in attention and executive control, which are crucial for daily functioning after a stroke.
2591011Eligibility Criteria
Adults over 40 with mild to moderate cognitive impairment from a stroke that happened more than a year ago. They need to be medically stable, able to follow instructions, and have adequate sight and hearing. A caregiver must be available, and they should be capable of traveling to the lab multiple times.Inclusion Criteria
I am physically and mentally fit to participate in the study.
You have some trouble with thinking and memory, as shown by a score of 10-26 on a test called the Montreal Cognitive Assessment.
You live at home, not in a hospital or nursing facility.
+7 more
Exclusion Criteria
I have cognitive issues due to a condition like Alzheimer's, brain injury, or substance abuse.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
1 visit (in-person)
Treatment
Participants receive 35 hours of training, including Speed of Processing Training (SOPT) and either Constraint-Induced Cognitive Therapy (CICT) or Brain Fitness-Health Education Lifestyle Program (BF-HELP).
2-4 weeks
10 in-home sessions, 10 in-lab sessions
Follow-up
Participants are monitored for transition of behavioral changes into everyday life, with follow-up phone calls for some groups.
12 months
4 weekly calls, then monthly calls for 11 months
Participant Groups
The trial compares two cognitive rehabilitation methods for post-stroke patients: Constraint-Induced Cognitive Therapy (CICT) which includes in-lab training on daily activities, and Brain Fitness-Health Education Lifestyle Program (BF-HELP), focusing on relaxation and healthy lifestyle integration.
4Treatment groups
Experimental Treatment
Active Control
Group I: CICT without Follow-up Phone CallsExperimental Treatment4 Interventions
Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.
Group II: CICT with Follow-up Phone CallsExperimental Treatment5 Interventions
Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.
Group III: BF-HELP with Follow-up Phone CallsActive Control5 Interventions
Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.
Group IV: BF-HELP without Follow-up Phone CallsActive Control5 Interventions
Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Institute on Aging (NIA)Collaborator
Posit ScienceCollaborator
References
A randomized control trial of the effects of home-based online attention training and working memory training on cognition and everyday function in a community stroke sample. [2023]Cognitive difficulties are common following stroke and can have widespread impacts on everyday functioning. Technological advances offer the possibility of individualized cognitive training for patients at home, potentially providing a low-cost, low-intensity adjunct to rehabilitation services. Using this approach, we have previously demonstrated post-training improvements in attention and everyday functioning in fronto-parietal stroke patients. Here we examine whether these benefits are observed more broadly in a community stroke sample. Eighty patients were randomized to either 4 weeks of online adaptive attention training (SAT), working memory training (WMT) or waitlist (WL). Cognitive and everyday function measures were collected before and after the intervention, and after 3 months. During training, weekly measures of patients' subjective functioning were collected. The training was well received and compliance good. No differences in our primary end-point, spatial bias, or other cognitive functions were observed. However, on patient-reported outcomes, SAT participants showed greater levels of improvement in everyday functioning than WMT or WL participants. In line with our previous work, everyday functioning improvements were greatest for patients with spatial impairments and those who received SAT training. Whether attention training can be recommended for stroke survivors depends on whether cognitive test performance or everyday functioning is considered more relevant.
Efficacy of computerized cognitive training on improving cognitive functions of stroke patients: A systematic review and meta-analysis of randomized controlled trials. [2022]To evaluate the effects of computerized cognitive training on the cognitive functions of stroke patients.
The Efficacy of the Speed of Processing Training Program in Improving Functional Outcome: From Restoration to Generalization. [2023]To examine the efficacy of Speed of Processing Training (SOPT) in improving everyday functional outcomes in persons with multiple sclerosis (MS).
The effects of computer-assisted cognitive rehabilitation on cognitive impairment after stroke: A systematic review and meta-analysis. [2022]To determine the effectiveness of computer-assisted cognitive rehabilitation in improving cognitive function in patients with post-stroke cognitive impairment.
The Effects of Computer Based Cognitive Rehabilitation in Stroke Patients with Working Memory Impairment: A Systematic Review. [2020]To evaluate benefits and harms for computer based cognitive rehabilitation (CBCR) on working memory impairment after stroke.
Vascular Cognitive Impairment After Mild Stroke: Connectomic Insights, Neuroimaging, and Knowledge Translation. [2022]Contemporary stroke assessment protocols have a limited ability to detect vascular cognitive impairment (VCI), especially among those with subtle deficits. This lesser-involved categorization, termed mild stroke (MiS), can manifest compromised processing speed that negatively impacts cognition. From a neurorehabilitation perspective, research spanning neuroimaging, neuroinformatics, and cognitive neuroscience supports that processing speed is a valuable proxy for complex neurocognitive operations, insofar as inefficient neural network computation significantly affects daily task performance. This impact is particularly evident when high cognitive loads compromise network efficiency by challenging task speed, complexity, and duration. Screening for VCI using processing speed metrics can be more sensitive and specific. Further, they can inform rehabilitation approaches that enhance patient recovery, clarify the construct of MiS, support clinician-researcher symbiosis, and further clarify the occupational therapy role in targeting functional cognition. To this end, we review relationships between insult-derived connectome alterations and VCI, and discuss novel clinical approaches for identifying disruptions of neural networks and white matter connectivity. Furthermore, we will frame knowledge translation efforts to leverage insights from cutting-edge structural and functional connectomics research. Lastly, we highlight how occupational therapists can provide expertise as knowledge brokers acting within their established scope of practice to drive substantive clinical innovation.
Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety. [2021]Background Physical exercise and cognitive training have been recommended to improve cognitive outcomes poststroke, but a multifaceted strategy including aerobic, resistance, and cognitive training to facilitate poststroke recovery has not been investigated. We aimed to assess the feasibility, adherence, and safety of a combined aerobic, resistance, and cognitive training intervention (CARET+CTI) after stroke. Methods and Results We prospectively randomized patients presenting with recent stroke to a comparison of a supervised 12-week CARET+CTI program and a control group receiving sham CARET+CTI. Participants were scheduled for 3 weekly CARET and CTI sessions. All participants underwent pre- and postintervention assessments of strength, endurance, and cognition. The primary outcomes were feasibility and adherence, defined as the ratio of scheduled and observed visits, and safety. We enrolled 131 participants, of whom 37 withdrew from the study. There were 17 (20%) withdrawals in the CARET+CTI and 20 (44%) in the control group. The observed-over-expected visit ratio was significantly higher in the intervention than in the control group (0.74±0.30 versus 0.54±0.38; P=0.003). A total of 99 adverse events were reported by 59 participants, none of which were serious and related to the intervention. Greater gains in physical, cognitive, and mood outcomes were found in the CARET+CTI group than in the control group, but were not statistically significant after adjustments. Conclusions A CARET+CTI intervention, after stroke, is safe, feasible, and has satisfactory participant adherence over 12 weeks. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT02272426.
Neurofeedback as a form of cognitive rehabilitation therapy following stroke: A systematic review. [2022]Neurofeedback therapy (NFT) has been used within a number of populations however it has not been applied or thoroughly examined as a form of cognitive rehabilitation within a stroke population. Objectives for this systematic review included: i) identifying how NFT is utilized to treat cognitive deficits following stroke, ii) examining the strength and quality of evidence to support the use of NFT as a form of cognitive rehabilitation therapy (CRT) and iii) providing recommendations for future investigations. Searches were conducted using OVID (Medline, Health Star, Embase + Embase Classic) and PubMed databases. Additional searches were completed using the Cochrane Reviews library database, Google Scholar, the University of Toronto online library catalogue, ClinicalTrials.gov website and select journals. Searches were completed Feb/March 2015 and updated in June/July/Aug 2015. Eight studies were eligible for inclusion in this review. Studies were eligible for inclusion if they: i) were specific to a stroke population, ii) delivered CRT via a NFT protocol, iii) included participants who were affected by a cognitive deficit(s) following stroke (i.e. memory loss, loss of executive function, speech impairment etc.). NFT protocols were highly specific and varied within each study. The majority of studies identified improvements in participant cognitive deficits following the initiation of therapy. Reviewers assessed study quality using the Downs and Black Checklist for Measuring Study Quality tool; limited study quality and strength of evidence restricted generalizability of conclusions regarding the use of this therapy to the greater stroke population. Progression in this field requires further inquiry to strengthen methodology quality and study design. Future investigations should aim to standardize NFT protocols in an effort to understand the dose-response relationship between NFT and improvements in functional outcome. Future investigations should also place a large emphasis on long-term participant follow-up.
Rehabilitation training improves cognitive disorder after cerebrovascular accident by improving BDNF Bcl-2 and Bax expressions in regulating the JMK pathway. [2022]To explore the effect of rehabilitation training on cognitive impairment after cerebrovascular accident and its potential mechanism.
Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. [2021]Deficits in attention and executive control are some of the most common, debilitating and persistent consequences of brain injuries. Understanding neural mechanisms that support clinically significant improvements, when they do occur, may help advance treatment development. Intervening via rehabilitation provides an opportunity to probe such mechanisms. Our objective was to identify neural mechanisms that underlie improvements in attention and executive control with rehabilitation training. We tested the hypothesis that intensive training enhances modulatory control of neural processing of perceptual information in patients with acquired brain injuries. Patients (n=12) participated either in standardized training designed to target goal-directed attention regulation, or a comparison condition (brief education). Training resulted in significant improvements on behavioural measures of attention and executive control. Functional magnetic resonance imaging methods adapted for testing the effects of intervention for patients with varied injury pathology were used to index modulatory control of neural processing. Pattern classification was utilized to decode individual functional magnetic resonance imaging data acquired during a visual selective attention task. Results showed that modulation of neural processing in extrastriate cortex was significantly enhanced by attention regulation training. Neural changes in prefrontal cortex, a candidate mediator for attention regulation, appeared to depend on individual baseline state. These behavioural and neural effects did not occur with the comparison condition. These results suggest that enhanced modulatory control over visual processing and a rebalancing of prefrontal functioning may underlie improvements in attention and executive control.
PRACTICAL ASPECTS AND RESULTS OF COGNITIVE THERAPY IN THE EARLY RECOVERY PERIOD OF ISCHEMIC STROKE. [2023]The aim: To determine the impact of cognitive training on the degree of cognitive functions recovery and quality of life in the early recovery period of ischemic stroke.