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Neurostimulation for cognitive rehabilitation in stroke (NeuroCog): study protocol for a randomized controlled trial.

ABSTRACT: Stroke patients may present severe cognitive impairments, primarily related to executive functions. Transcranial direct current stimulation has shown promising results, with neuromodulatory and neuroplastic effects. This study is a double-blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in two different cognitive regions after a stroke.Sixty patients who suffer from chronic strokes will be randomized into one of four groups: dorsolateral prefrontal cortex, cingulo-opercular network, motor primary cortex and sham stimulation. Each group will receive transcranial direct current stimulation at an intensity of 2 mA for 20 minutes daily for 10 consecutive days. Patients will be assessed with a Dysexecutive Questionnaire, Semantic Fluency Test, categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence Scale, Rey Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at baseline and after their tenth stimulation session. Those who achieve clinical improvement with neurostimulation will be invited to receive treatment for 12 months as part of a follow-up study.Long-term stimulation could be analyzed in regard to possible adaptive changes on plasticity after structural brain damage and if these changes are different in terms of clinical improvement when applied to two important cognitive centers.Clinicaltrials.gov, NCT02315807 . 9 December 2014.

SUBMITTER: Andrade SM

PROVIDER: S-EPMC4589066 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Neurostimulation for cognitive rehabilitation in stroke (NeuroCog): study protocol for a randomized controlled trial.

Andrade Suellen Marinho SM Fernández-Calvo Bernardino B Boggio Paulo Sérgio PS de Oliveira Eliane Araújo EA Gomes Lilze Franklim LF Pinheiro Júnior José Eudes Gomes JE Rodrigues Rafaela Martins RM de Almeida Natália Leandro NL Moreira Gioconda Marla de Siqueira GM Alves Nelson Torro NT

Trials 20150929

<h4>Background</h4>Stroke patients may present severe cognitive impairments, primarily related to executive functions. Transcranial direct current stimulation has shown promising results, with neuromodulatory and neuroplastic effects. This study is a double-blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in two different cognitive regions after a stroke.<h4>Methods/design</h4>Sixty patients who suffer from chronic strokes will be randomized into one o ...[more]

PMID: 26420269

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Project description:Background: Stroke is a leading cause of disability. Nonetheless, the care pathway for stroke rehabilitation takes partially into account the needs of chronic patients. This is due in part to the lack of evidence about the mechanisms of recovery after stroke, together with the poor knowledge of related and influencing factors. Here we report on the study protocol "Rehabilitation and Biomarkers of Stroke Recovery," which consists of 7 work-packages and mainly aim to investigate the effects of long-term neurorehabilitation on stroke patients and to define a related profile of (clinical-biological, imaging, neurophysiological, and genetic-molecular) biomarkers of long-term recovery after stroke. The work-package 1 will represent the main part of this protocol and aims to compare the long-term effects of intensive self-rehabilitation vs. usual (rehabilitation) care for stroke. Methods: We planned to include a total of 134 adult subacute stroke patients (no more than 3 months since onset) suffering from multidomain disability as a consequence of first-ever unilateral ischemic stroke. Eligible participants will be randomly assigned to one of the following groups: intensive self-rehabilitation (based on the principles of "Guided Self-Rehabilitation Contract") vs. usual care (routine practice). Treatment will last 1 year, and patients will be evaluated every 3 months according to their clinical presentation. The following outcomes will be considered in the main work-package: Fugl-Meyer assessment, Cognitive Oxford Screen Barthel Index, structural and functional neuroimaging, cortical excitability, and motor and somatosensory evoked potentials. Discussion: This trial will deal with the effects of an intensive self-management rehabilitation protocol and a related set of biomarkers. It will also investigate the role of training intensity on long-term recovery after stroke. In addition, it will define a set of biomarkers related to post-stroke recovery and neurorehabilitation outcome in order to detect patients with greater potential and define long-term individualized rehabilitation programs. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04323501.

Project description:BackgroundStroke patients usually suffer primary cognitive impairment related to attention, memory, and executive functions. This impairment causes a negative impact on the quality of life of patients and their families, and may be long term. Cognitive rehabilitation has been shown to be an effective way to treat cognitive impairment and should be continued after hospital discharge. Computerized cognitive rehabilitation can be performed at home using exercise programs that advance with predetermined course content, interval, and pace. We hypothesize that computerized rehabilitation might be improved if a program could customize course content and pace in response to patient-specific progress. The present pilot study is a randomized controlled double-blind crossover clinical trial aiming to study if chronic stroke patients with cognitive impairment could benefit from cognitive training through a customized tele-rehabilitation platform ("Guttmann, NeuroPersonalTrainer"®, GNPT®).Methods/designIndividuals with chronic-stage stroke will be recruited. Participants will be randomized to receive experimental intervention (customized tele-rehabilitation platform, GNPT®) or sham intervention (ictus.online), both with the same frequency and duration (five sessions per week over 6 weeks). After a washout period of 3 months, crossover will occur and participants from the GNPT® condition will receive sham intervention, while participants originally from the sham intervention will receive GNPT®. Patients will be assessed before and after receiving each treatment regimen with an exhaustive neuropsychological battery. Primary outcomes will include rating measures that assess attention difficulties, memory failures, and executive dysfunction for daily activities, as well as performance-based measures of attention, memory, and executive functions.DiscussionCustomized cognitive training could lead to better cognitive function in patients with chronic-stage stroke and improve their quality of life.Trial registrationNCT03326349 . Registered 31 October 2017.

Project description:BackgroundCognitive problems are common in non-central nervous system cancer survivors. These problems are perceived as an important contributor to decline in work performance and work ability. Various interventions for cognitive problems have been proposed, but effectiveness regarding work-related outcomes has not yet been established. Effective treatment options to alleviate the adverse influence of cognitive problems on work performance are needed for working cancer survivors. In this paper, we will describe the design of a randomized, controlled, multicenter trial that evaluates the (cost-)effectiveness of an Internet-based cognitive rehabilitation program for occupationally active cancer survivors confronted with cognitive problems.Methods/ designA three-armed randomized controlled trial will be conducted, including two intervention groups (i.e., basic and extensive cognitive rehabilitation program) and one waitlist control group. In total, 261 cancer survivors (18-65?years) who have returned to work and who experience cognitive problems will be recruited. Patients with and without cognitive impairment as established in a neuropsychological assessment will be eligible; stratification will take place based on the presence of this cognitive impairment. The extensive intervention arm will contain a comprehensive training program (including psycho-education, fatigue management, and cognitive strategy training) with individual guidance (blended intervention). The basic intervention arm will contain a brief cognitive training program (including psycho-education and fatigue management) without individual guidance. The primary outcome will be accomplishment of an individually defined work-related treatment goal. Secondary outcomes include, among others, subjective cognitive functioning, work functioning, and quality of life. Primary and secondary outcomes will be measured at baseline (T0) and at 12?weeks (T1) and 26?weeks (T2) post-randomization.DiscussionAbout 40-50% of the cancer patients worldwide are of working age at time of diagnosis. Many of the occupationally active cancer survivors experience cognitive problems. Both from an individual and a societal perspective, it is important to sustain cancer survivors' employability. An effective treatment to alleviate the impact of cognitive decline and to improve work ability might help cancer survivors to sustain employability.Trial registrationClinicalTrials.gov NCT03900806 . Registered on 03 April 2019 (current status: ongoing).

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Neurostimulation for cognitive rehabilitation in stroke (NeuroCog): study protocol for a randomized controlled trial.

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Neurostimulation for cognitive rehabilitation in stroke (NeuroCog): study protocol for a randomized controlled trial.

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