Spatial-Motor Stroke-Rehab Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorEmory University
About this trial
The purpose of this study is to understand how prism adaptation training with and without electrical stimulation changes visuospatial behavior, motor system neurophysiology, and walking dysfunction.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-30 years
Able-Bodied (healthy without any physical disability or neurological disorder)
45-90 years
Able-Bodied (healthy without any physical disability or neurological disorder)
Disqualifiers
History or evidence of orthopedic or physical disability
History or evidence of neurological pathology
Pregnancy (female)
Uncontrolled hypertension
Trial design
Design model
Crossover
Treatments tested in this trial
Prism adaptation therapy (PAT) + Electrical stimulation (E-stim)
DevicePAT requires one to wear prism lenses while making arm-reaching movements toward visual targets. For treating left-sided neglect, a person wears the prism lenses that shift the visual field, including the images of the target and of one's own reaching arm, certain degrees to the right depending on the diopter of the lens (e.g., the 20-diopter lens shifts the visual field by 11.4 degrees). The visual system adapts over the repetitive practice of the arm reaching toward the target. The person eventually achieves success with a leftward movement reaching the actual target. Electrical stimulation (E-stim) involves parameters and settings commonly used in clinical practice as well as research for pain relief and other applications, commonly referred to as transcutaneous electrical nerve stimulation (TENS). TENS and E-stim are delivered using FDA-approved, commercially available portable clinical transcutaneous electrical stimulators (e.g. Empi TENS Unit).
Prism adaptation therapy (PAT) + Sham Stimulator
DeviceParticipants in the PAT with sham stim condition group will receive sham electrical stimulation treatment (electrodes will be attached but the stimulator will not be turned on) to the left upper limb with the same placement of electrodes while undergoing PAT.
Gait Training
Other interventionAfter PAT, participants will complete multiple 30-seconds to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts.
Treatment groups
65 Participants
are divided into 3 treatment groupsGroup A: Young Able-Bodied individualsActive comparator 2 interventions
Group B: Old Able-Bodied individualsActive comparator 2 interventions
Group C: Stroke with Spatial Neglect (SN) individualsExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change in visuospatial pointing behavior
Measured by the neuropsychological laboratory pointing behavior with the Kessler Foundation Neglect Assessment Process (KF-NAP) tool. Patients are asked to point with their eyes closed towards the center (proprioceptive pointing) and eyes open towards a target (visuo-proprioceptive pointing) on a standing calibrated board unaffected hand). The test is scored by measuring the deviation from 0 (midline). Pre-PAT and post-PAT measures are compared, there is no minimum or maximum score. A more negative score (Pre to Post) means improvement in visuospatial alignment (Improved left spatial neglect) in people post-stroke.
Time frame
Pre-training and immediately after training session2
Change in intracortical excitability [paired pulse transcranial Magnetic Stimulation (TMS)]
Primary Motor Cortex (M1) and TMS from the hand muscles (first dorsal interossei) and the ankle (soleus) will be measured using Computer software (Biopac) that will record the muscle's responses to TMS pulses (MEPs) through electromyography (EMG) sensors attached to the skin of the legs and/or arms.
Time frame
Pre-training and immediately after training session3
Change in corticospinal excitability (single pulse TMS)
Change in corticospinal excitability measured by the change from baseline in motor evoked potentials (MEP) amplitude responses from the hand muscles (first dorsal interossei) and the ankle (soleus) will be measured using Computer software (Biopac) that will record the muscle's responses to TMS pulses (MEPs) through electromyography (EMG) sensors attached to the skin of the legs and/or arms.
Time frame
Pre-training and immediately after training sessionSecondary outcomes
1
Change in spatial neglect deficits
Measured by the clinical tests Behavioral Inattention Test (BIT). The BIT Conventional (BITC) subtest consists of 6 items: line crossing, letter cancelation, star cancellation, figure and shape copying, line bisection, and representational drawing. The Cut-offs score for the BITC is 129 out of 146. Higher scores are indicative of more severe visual impairment.
Time frame
Pre-training and immediately after training session2
Change in computerized line bisection task
Participants are asked to perform the conventional 24cm line bisection task on a 14-inch screen computer screen, placed 55cm from a seated position, with the unaffected hand using a mouse. There are 64 lines, half of which are in normal condition and half in reversed condition. The test is scored by measuring the deviation of the bisection from the true center of the line. A deviation negative of zero (0) is indicative of spatial neglect; Pre-PAT and post-PAT measures are compared, and a negative score reflects a shift to the left visual space- the effect of PAT
Time frame
Pre-training and immediately after training session3
Change in the Catherine Bergego Scale (CBS)
Measured by a validated assessment tool that is sensitive to SN and its functional sequela; CBS motor items have been validated to identify Aiming SN. The CBS uses a 4-point rating scale to indicate the severity of neglect for each item: 0 = no neglect 1. = mild neglect (patient always explores the right hemispace first and slowly or hesitantly explores the left side) 2. = moderate neglect (patient demonstrates constant and clear left-sided omissions or collisions) 3. = severe neglect (patient is only able to explore the right hemispace) This results in a total score of 30. Reported arbitrary ratings of neglect severity according to total scores: 0 = No behavioral neglect 1-10 = Mild behavioral neglect 11-20 = Moderate behavioral neglect 21-30 = Severe behavioral neglect
Time frame
Pre-training and immediately after training session4
Change in weight-bearing asymmetry
This outcome will be measured only in participants who have had a stroke. Force platform data obtained from a dual-belt instrumented treadmill during 3-d motion capture will be used to calculate inter-limb asymmetry in vertical ground reaction forces in standing and during the stance phase of gait.
Time frame
Pre-training and immediately after training sessionSponsors and contacts
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Emory University
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov