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A Novel Multimodal Approach to Promote Motor Recovery and Plasticity After Stroke

10 de novembro de 2026 atualizado por: Amit Sethi, University of Utah

Upper extremity (UE) paresis or weakness is one of the most frequent impairments after stroke. Despite intense rehabilitation, motor and functional recovery of patients with severe hand impairments is poor. Hence, there is a need for more effective treatments to enhance motor function in patients with severe hand impairments after stroke. Adaptive functional electrical stimulation (FES) appears to be a promising treatment and has the potential to facilitate active movement in individuals with severe impairments post-stroke. In addition, transcranial random noise stimulation (trns) is a widely studied, non-invasive and safe method to enhance the corticomotor excitability in individuals with chronic stroke. However, the effect of combining trns and adaptive FES in patients with severe hand impairments has not been investigated. Therefore, the purpose of this study is to investigate whether combining trns with FES will enhance hand function in individuals with chronic stroke than FES alone. The investigators predict that combining trns with FES will significantly enhance hand function than FES alone.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

The primary purpose of this study was to investigate whether combining transcranial random noise stimulation with functional electrical stimulation-facilitated task practice will enhance hand function in individuals with severe paresis post-stroke than functional electrical stimulation alone.

The study is an experimental randomized study comparing the effects of transcranial random noise stimulation with functional electrical stimulation to functional electrical stimulation alone on recovery of function in the more-affected hand in individuals with chronic stroke.

Participants were randomized to receive transcranial random noise stimulation and functional electrical stimulation-facilitated task practice or sham-transcranial random noise stimulation and functional electrical stimulation-facilitated task practice.

Participants received 18 treatment sessions over 6 weeks (3 times/week for 6-8 weeks).

Tipo de estudo

Intervencional

Inscrição (Estimado)

78

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Ainda não está recrutando
        • University of Utah
      • Salt Lake City, Utah, Estados Unidos, 84108
        • Recrutamento
        • University of Utah
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Female and male subjects are eligible for inclusion only if all of the following criteria are met:

  1. Age between 40-85 years
  2. Diagnosis of first-ever subcortical stroke (single cerebrovascular accident)
  3. Stroke onset of at least six months prior to the time of participation
  4. Limited functional wrist and finger flexion and extension, as indicated between 5º-20º active movement
  5. Cognitive skills to actively participate, as indicated by scores of ≥ 24 on the Mini-Mental Status Examina-tion
  6. English speaking

Exclusion Criteria:

A subject is not eligible for inclusion if any of the following criteria apply:

  1. Presence of severe aphasia preventing the ability to follow 1-step directions at least 80% of the time
  2. Excessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score >2
  3. Diagnosis of neurological disorders other than stroke
  4. History of recent seizure or epilepsy while taking anticonvulsants
  5. Orthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremity
  6. Presence of metallic implants in the head or neck
  7. Currently or planning to become pregnant
  8. Difficulty maintaining alertness or remaining still
  9. Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for MRI)
  10. Bodyweight > 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI)
  11. Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic medication
  12. Participation in concurrent occupational therapy

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Falso: sham-tRNS and FES-assisted task-specific practice

Participants will receive the intervention 3x/week for 6-8 weeks for a total of 18 intervention sessions. Participants will receive sham-tRNS during the FES-assisted task-specific practice.
Dispositivo: FES (Functional Electrical Stimulation)-assisted task-specific practice

The FES-assisted task-specific practice will focus on restituting the movement components composing functional tasks. We will use the principles of motor learning with FES-assisted task-specific practice. Based on motor learning principles, our intervention will include 1) movement practice as close to normative as possible, 2) a high number of repetitions, 3) attention to the motor task, and 4) training specificity.

Dispositivo: Sham-tRNS (Transcranial Random Noise Stimulation)

Individuals in this group will receive sham-tRNS via the same electrode configuration as the tRNS. The stimulation will gradually ramp up for 30 seconds and then fade away for the rest of the intervention session.
Experimental: tRNS and FES-assisted task-specific practice

Participants will receive the intervention 3x/week for 6-8 weeks for a total of 18 intervention sessions. Participants will receive tRNS during the FES-assisted task-specific practice.
Dispositivo: FES (Functional Electrical Stimulation)-assisted task-specific practice

The FES-assisted task-specific practice will focus on restituting the movement components composing functional tasks. We will use the principles of motor learning with FES-assisted task-specific practice. Based on motor learning principles, our intervention will include 1) movement practice as close to normative as possible, 2) a high number of repetitions, 3) attention to the motor task, and 4) training specificity.

Dispositivo: tRNS (Transcranial Random Noise Stimulation)

Individuals in this group will receive tRNS at 2 mA intensity between 101-640 Hz. The current will be gradually ramped up for and down for the first and last 30 seconds of the stimulation.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Upper Extremity Fugl-Meyer Scale
Prazo: 6-9 weeks post-intervention

Changes in Upper Extremity Fugl-Meyer between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. This scale measures voluntary motor control of the paretic upper extremity (UE) using a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. The total possible score ranges from 0-66 with higher scores indicating a better voluntary motor control of the paretic UE.
6-9 weeks post-intervention
Stroke Impact Scale - Hand Function Score
Prazo: 6-9 weeks post-intervention

Changes in Stroke Impact Scale - Hand Function Score between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Participants report paretic upper extremity (UE) use in five commonly performed daily tasks (e.g., carry a bag of groceries) using a 5-point ordinal scale, which ranges from 0-5, where 0=cannot use paretic and 5=not difficult at all to use paretic UE. The total score ranges from 0-25 with higher scores indicating better UE function.
6-9 weeks post-intervention
Transcranial Magnetic stimulation-induced motor evoked potential
Prazo: 6-9 weeks post-intervention

Changes in cortical motor evoked potentials (MEPs) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. MEPs will be obtained by placing a transcranial magnetic stimulation (TMS) coil over the hand knob of the ipsilesional primary motor cortex. TMS-induced MEP amplitude will be obtained by averaging peak to peak amplitudes of 20 MEPs from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of MEP indicate greater corticospinal excitability.
6-9 weeks post-intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Upper Extremity Fugl-Meyer Scale
Prazo: 12-14 weeks post intervention

Changes in Upper Extremity Fugl-Meyer between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. This scale measures voluntary motor control of the paretic upper extremity (UE) using a 3-point ordinal scale where 0=cannot perform, 1=performs partially, and 2=performs fully. The total possible score ranges from 0-66 with higher scores indicating a better voluntary motor control of the paretic UE.
12-14 weeks post intervention
Stroke Impact Scale - Hand Function Score
Prazo: 12-14 weeks post intervention

Changes in Stroke Impact Scale - Hand Function Score between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Participants report paretic upper extremity (UE) use in five commonly performed daily tasks (e.g., carry a bag of groceries) using a 5-point ordinal scale, which ranges from 0-5, where 0=cannot use paretic and 5=not difficult at all to use paretic UE. The total score ranges from 0-25 with higher scores indicating better UE function.
12-14 weeks post intervention
Transcranial Magnetic stimulation-induced motor evoked potential
Prazo: 12-14 weeks post intervention

Changes in cortical motor evoked potentials (MEPs) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. MEPs will be obtained by placing a transcranial magnetic stimulation (TMS) coil over the hand knob of the ipsilesional primary motor cortex. TMS-induced MEP amplitude will be obtained by averaging peak to peak amplitudes of 20 MEPs from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of MEP indicate greater corticospinal excitability.
12-14 weeks post intervention

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Grip Strength of the paretic hand
Prazo: 6-9 weeks Post-intervention

Changes in Grip Strength between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Average grip strength of the of three trials will be reported in kilograms. Higher values indicate better grip strength.
6-9 weeks Post-intervention
Grip Strength of the paretic hand
Prazo: 12 -14 weeks Post-intervention

Changes in Grip Strength between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Average grip strength of the of three trials will be reported in kilograms. Higher values indicate better grip strength.
12 -14 weeks Post-intervention
Upper extremity muscle synergy
Prazo: 6-9 weeks Post-intervention

Changes in upper extremity muscle synergy between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Transcranial magnetic stimulation induced motor evoked potentials of different proximal and distal upper extremity muscles are coupled using the synergy weights and activation profiles obtained with a novel Principal component-based motor evoked potential analyses. Higher values suggest better muscle synergy.
6-9 weeks Post-intervention
Upper extremity muscle synergy
Prazo: 12-14 weeks Post-intervention

Changes in upper extremity muscle synergy between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Transcranial magnetic stimulation induced motor evoked potentials of different proximal and distal upper extremity muscles are coupled using the synergy weights and activation profiles obtained with a novel Principal component-based motor evoked potential analyses. Higher values suggest better muscle synergy.
12-14 weeks Post-intervention
Upper Extremity range of motion via kinematics
Prazo: 6-9 weeks Post-intervention

Changes in Upper Extremity kinematics between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. 3D biomechanical data will be collected using a motion capture system. We will evaluate maximum finger excursions. Higher values indicate greater finger excursion.
6-9 weeks Post-intervention
Upper Extremity range of motion via kinematics
Prazo: 12-14 weeks Post-intervention

Changes in Upper Extremity kinematics between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. 3D biomechanical data will be collected using a motion capture system. We will evaluate maximum finger excursions. Higher values indicate greater finger excursion.
12-14 weeks Post-intervention
Muscle strength and activation
Prazo: 6-9 weeks Post-intervention

Changes in muscle strength and activation between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Muscle strength and activation testing will be performed using the triple interpolated twitch technique for the paretic wrist and hand muscles. We will test muscle strength and activation using a customized set-up with load cells for the wrist and hand. Normalized peak force/torque will be used to calculate strength and activation. Higher values indicate greater muscle strength and activation.
6-9 weeks Post-intervention
Muscle strength and activation
Prazo: 12-14 weeks Post-intervention

Changes in muscle strength and activation between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Muscle strength and activation testing will be performed using the triple interpolated twitch technique for the paretic wrist and hand muscles. We will test muscle strength and activation using a customized set-up with load cells for the wrist and hand. Normalized peak force/torque will be used to calculate strength and activation. Higher values indicate greater muscle strength and activation.
12-14 weeks Post-intervention
Action Research Arm Test
Prazo: 6-9 weeks Post-intervention

Changes in Action Research Arm Test between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Action Research Arm Test evaluates upper extremity (UE) functional performance using a 4-point ordinal scale on 19-items, which are divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total possible score ranges from 0-57 with higher scores indicating higher UE function.
6-9 weeks Post-intervention
Action Research Arm Test
Prazo: 12-14 weeks Post-intervention

Changes in Action Research Arm Test between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. Action Research Arm Test evaluates upper extremity (UE) functional performance using a 4-point ordinal scale on 19-items, which are divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total possible score ranges from 0-57 with higher scores indicating higher UE function.
12-14 weeks Post-intervention
Social role sub-scale of Assessment of Life Habits
Prazo: 6-9 weeks Post-intervention

Changes in Social role sub-scale of Assessment of Life Habits between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. The Social-LIFE-H assess the quality of social participation by estimating the perceived difficulty an in-dividual faces in performing a life habit and the type of assistance required to perform it. Using 40 items, the sub-scale assesses restrictions in social responsibilities, interpersonal relationships, community life, education, employment, and leisure. Each item is scored using a 10-point ordinal scale, which ranges from 0-9, where 0 = not able to perform and 9 = able to perform without difficulty with higher scores indicating better social participation. The total possible score will be reported, which is obtained by summing the scores on each item and then dividing by the number of items.
6-9 weeks Post-intervention
Social role sub-scale of Assessment of Life Habits
Prazo: 12-14 weeks Post-intervention

Changes in Social role sub-scale of Assessment of Life Habits between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. The Social-LIFE-H assess the quality of social participation by estimating the perceived difficulty an in-dividual faces in performing a life habit and the type of assistance required to perform it. Using 40 items, the sub-scale assesses restrictions in social responsibilities, interpersonal relationships, community life, education, employment, and leisure. Each item is scored using a 10-point ordinal scale, which ranges from 0-9, where 0 = not able to perform and 9 = able to perform without difficulty with higher scores indicating better social participation. The total possible score will be reported, which is obtained by summing the scores on each item and then dividing by the number of items.
12-14 weeks Post-intervention
Transcranial magnetic stimulation induced cervicomedullary motor evoked potential
Prazo: 6-9 weeks Post-intervention

Changes in transcranial magnetic stimulation (TMS) induced cervicomedullary motor evoked potential (CMEP) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. An average peak to peak amplitudes of 20 CMEPs will be reported from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of CMEP indicate greater spinal excitability.
6-9 weeks Post-intervention
Transcranial magnetic stimulation induced cervicomedullary motor evoked potential
Prazo: 12-14 weeks Post-intervention

Changes in transcranial magnetic stimulation (TMS) induced cervicomedullary motor evoked potential (CMEP) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. An average peak to peak amplitudes of 20 CMEPs will be reported from the flexor carpii radials and/or extensor digitorum communis muscles. Higher values of CMEP indicate greater spinal excitability.
12-14 weeks Post-intervention
H-reflex excitability
Prazo: 6-8 weeks Post-intervention

Changes in H-reflex excitability (measured by H-max/M-max ratio) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. H- and M- recruitment curves will be mapped for the paretic flexor carpii radials muscle. Higher values indicate greater spinal excitability.
6-8 weeks Post-intervention
H-reflex excitability
Prazo: 12 -14 weeks Post-intervention

Changes in H-reflex excitability (measured by H-max/M-max ratio) between the experimental (tRNS and FES-assisted task-specific practice) and control (sham-tRNS and FES-assisted task-specific practice) conditions. H- and M- recruitment curves will be mapped for the paretic flexor carpii radials muscle. Higher values indicate greater spinal excitability.
12 -14 weeks Post-intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Utah

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

11 de novembro de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2030

Conclusão do estudo (Estimado)

15 de fevereiro de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

1 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de outubro de 2026

Primeira postagem (Real)

22 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 00193557

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

produto fabricado e exportado dos EUA

Não

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