Improving Measurement and Treatment of Post-stroke Neglect
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
This study examines how to best assess and treat post-stroke neglect. This study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. This study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ischemic or hemorrhagic stroke 3 months post stroke
Fugl-Meyer Upper Extremity (FMA-Upper Extremity) score between 20-56/60
Inducible motor evoked potential (MEP) of the abductor pollicis brevis (APB) on the paretic stimulation (TMS)
Demonstrate the presence of unilateral neglect (Virtual Reality Lateralized Attention Test score <18)
Disqualifiers
History of cortical hemorrhagic stroke
history of seizures
history of brain tumor
hardware in skull or spine (e.g. coils, clips)
Trial design
Design model
Crossover
Treatments tested in this trial
Sham transcranial direct current stimulation (tDCS)
DeviceSham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete functional movements during the 30 minute train
Active direct current stimulation (tDCS)
DeviceSham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete functional movements during the 30 minute train
Treatment groups
17 Participants
are divided into 2 treatment groupsGroup A: Sham transcranial direct current stimulation (tDCS) plus repetitive task-specific practice (RTP)Sham comparator 1 intervention
Group B: Active tDCS plus RTPActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in excitability of fronto-parietal connectivity
Excitability of fronto-parietal connectivity measured by paired pulse twin coil transcranial magnetic stimulation (TMS) test. In each session, the difference in excitability of fronto-parietal connectivity between pre and post stimulation will be measured.
Time frame
Participants will be assessed at baseline and 30 minutes laterSecondary outcomes
1
Change in upper extremity kinematics
A kinematic assessment will be conducted to assess changes in motor impairment.
Time frame
Participants will be assessed at baseline and 30 minutes later2
Change on Behavioral Inattention Test
A neglect assessment (conventional subtests) will be conducted to assess changes in attentional impairment. Total scores range from 0-146 with lower scores indicating greater impairment.
Time frame
Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition)Other outcomes
1
Catherine Bergego Scale
This neglect assessment will be administered to examine the impact of neglect on performance of daily activities. Total scores range from 0-30 with higher scores indicating greater impairment.
Time frame
Participants in the cross-sectional study will be assessed at baseline.2
Behavioral Inattention Test
This neglect assessment (behavioral subtests) will be administered to examine the impact of neglect on performance of daily activities. Total scores range from 0-81 with lower scores indicating greater impairment.
Time frame
Participants in the cross-sectional study will be assessed at baseline.3
Naturalistic Action Test
This neglect assessment will be administered to examine the impact of neglect on performance of daily activities. Each item has a score of 0-6 with lower scores indicating greater impairment. The Lateralized Attention Score (LAS) is difference between the contralateral and ipsilateral proportion of items. Higher LAS scores indicate greater impairment.
Time frame
Participants in the cross-sectional study will be assessed at baseline.Sponsors and contacts
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Source ClinicalTrials.gov