Functional Neuroimaging and Motor Recovery After Stroke

NCT07666165 | Completed

• 2 other identifiers: 112546717SDG33690002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The primary goal of this project is to establish whether fMRI measurements of brain connectivity measured before and after interaction with a sensorimotor task can predict subsequent training-induced gains in motor function in a population of individuals with chronic stroke. This study involves individuals with chronic motor impairment resulting from stroke. The procedures include one fMRI session (baseline), followed by twelve training visits (2 or 3 times per week over 4-5 weeks) focused on training motor function of the hand and wrist conducted with a physical therapist. During imaging, participants interact with an MRI-compatible joystick that will cue participants to move their wrist in a controlled way. Before and after the training program, subjects will undergo behavioral testing with a physical therapist to quantify changes in clinical measures of impairment.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from pre-post task changes in resting-state functional connectivity

  The primary outcome is the goodness of fit (R\^2) of a regression model relating brain connectivity measures (predictors) to gains in motor function after stroke (clinical measurement). Predictors: resting-state functional connectivity measured using resting-state fMRI (rs-fMRI). Connectivity is quantified as Fisher-transformed correlation coefficients (z scores, unitless) of signal measured in pairs of regions (edges) within the cortico-thalamic-cerebellar network. Predictors include baseline (pre-task) connectivity and connectivity changes calculated as the difference between post-task and pre-task rs-fMRI measurements. Clinical measurement: change in Upper Extremity Fugl-Meyer Assessment (FM-UE) score (units: points), calculated as post-intervention FM-UE minus pre-intervention FM-UE. Outcome: model goodness of fit (R\^2, unitless). We use a custom LASSO-based variable selection method to construct the final model given multiple predictors and quantify the model fit via R\^2.

  Brain connectivity is measured during the MRI visit conducted at Baseline. rsFMRI scans are collected within 10 minutes before and after a motor task. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.

Secondary Outcomes (1)

• Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from corticospinal tract injury

  Structural brain scan (FLAIR) is acquired once during the MRI visit at Baseline. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.

Study Arms (1)

Conventional Physical Therapy Intervention

EXPERIMENTAL

The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10.

Behavioral: Conventional Physical Therapy Intervention

Interventions

Conventional Physical Therapy Intervention BEHAVIORAL

The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10.

Conventional Physical Therapy Intervention

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age comprised between 35 and 85 years
• diagnosis of a single unilateral subcortical stroke event occurring more than 6 months prior to enrollment resulting in upper extremity paresis (weakness) of one arm,
• presence of residual upper extremity motor function, demonstrated by the ability to actively supinate (rotate hand toward "palm-up" direction) the paretic forearm to neutral and to voluntarily extend (bend wrist toward back of the hand) and radially deviate (bend wrist toward thumb side) the paretic wrist at least 5 degrees,
• adequate cognition to provide informed consent and fully follow instruction (MOCA score of at least 19),
• English-speaking

You may not qualify if:

• more than 1 stroke,
• clinical or radiological evidence of damage to the cerebellum or brainstem,
• contra-indications to MRI (i.e. pacemakers, cochlear implants, neurostimulators, metallic implants, pregnancy, claustrophobia, permanent metal braces, or other implanted devices not approved for 3T imaging - see CBBI MRI Safety Checklist for details),
• weight \>400 pounds and/or unable or too uncomfortable to fit the torso into the MRI bore,
• musculoskeletal or other neurologic (non-stroke) conditions directly affecting the paretic wrist or hand function (such as tendinitis, arthritis, hand or wrist orthopaedic surgery in the last 6 months, diagnosis of carpal tunnel, multiple sclerosis, Parkinson's disease, etc.)
• inability to follow instructions on the motor task or understand protocol description (e.g. due to cognitive deficits)
• participation in additional Occupational or Physical Therapy in which they are doing hand/arm exercises while enrolled in this study
• received Botox injections in the past 3 months prior to or during participation in the study

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (2)

Center for Biomedical and Brain Imaging

Newark, Delaware, 19713, United States

Location

STAR Health Sciences Complex

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 24, 2026
• Study Start: January 25, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)