StrokeNCT03317860
Improving Measurement and Treatment of Post-stroke Neglect
A study testing Active direct current stimulation (tDCS) in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Active direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- History of cortical hemorrhagic stroke
- Presence of any MRI, TMS, tDCS risk factors including:
- history of seizures
- history of brain tumor
- hardware in skull or spine (e.g. coils, clips)
- implantable medical device (e.g. pacemaker)
Show all 11Show fewer
- metal in body (not compatible with MRI)
- pregnancy
- Severe spasticity (Modified Ashworth Scale score 3)
- Severe aphasia or cognitive impairment limiting participants' comprehension (National Institutes of Health Stroke Scale Level of Consciousness Commands Item score 1 or Best Language Item score 2)
- Unable to travel to UE Motor Function Laboratory at the Center for Rehabilitation Research in Neurological Conditions (a collaborative, Memorandum of Understanding (MOU) approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Amy Boos, (412) 648-4179, amy.boos2@va.gov
Katie L Mullen, (412) 822-3661, Katie.Mullen@va.gov
About this study
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.
Read the detailed description
It is very common for stroke survivors to have difficulty attending to one side of their body or space (neglect). Stroke survivors with neglect not only demonstrate impairments in attention but they also experience motor impairment. These individuals also have an imbalance in excitation in the brain. This study will examine the preliminary effects of non-invasive brain stimulation (transcranial direct current stimulation, tDCS) combined with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with neglect following stroke. The investigators will examine the effects of the intervention on brain excitability, upper extremity motor impairment, and attentional impairment. This study will also examine assessment of neglect. There are many clinical assessments designed to assess neglect; however, it is unknown whether items from some of the most commonly used assessments are able to effectively measure neglect or whether items from these assessments can be combined. Clinicians rely on clinical assessments to inform treatment and document patient progress. Therefore, it is important that investigators more closely examine these existing assessments.
- Conditions
- Stroke
- Being tested
- Sham transcranial direct current stimulation (tDCS), Active direct current stimulation (tDCS)
- Keywords
- perceptual disorders, cerebrovascular disorders, neurobehavioral manifestations, neurologic manifestations, neglect, non-invasive brain stimulation, rehabilitation, tDCS, paresis
- Medical subject headings
- Stroke, Perceptual Disorders, Cerebrovascular Disorders, Neurobehavioral Manifestations, Neurologic Manifestations, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham transcranial direct current stimulation (tDCS)Device
Also called noninvasive brain stimulation, transcranial direct current stimulation
Sham 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)Device
Also called noninvasive brain stimulation, transcranial direct current stimulation
Sham 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
| Study group | Role | What they receive |
|---|---|---|
| Sham transcranial direct current stimulation (tDCS) plus repetitive task-specific practice (RTP) | Sham comparator | Single session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP) Receives: Device: Sham transcranial direct current stimulation (tDCS) |
| Active tDCS plus RTP | Active comparator | Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP) Receives: Device: Active direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be assessed at baseline and 30 minutes later
Secondary outcomes (2)
Change in upper extremity kinematics
A kinematic assessment will be conducted to assess changes in motor impairment.
Measured: Participants will be assessed at baseline and 30 minutes later
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.
Measured: Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start2 Jul 2018
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Emily S. Grattan, PhD MS BS, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317860
- Sponsor's protocol ID
- N2420-W
- Other IDs
- 1IK2RX002420-01A2
- Status last verified
- Sep 2026
- First submitted
- 18 Oct 2017
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
PubMed 34196963
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Measurement and Treatment of Post-stroke Neglect
- ClinicalTrials.gov ID
- NCT03317860
- Acronym / sponsor ID
- N2420-W
- Conditions
- Stroke
- Keywords
- perceptual disorders, cerebrovascular disorders, neurobehavioral manifestations, neurologic manifestations, neglect, non-invasive brain stimulation, rehabilitation, tDCS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is very common for stroke survivors to have difficulty attending to one side of their body or space (neglect). Stroke survivors with neglect not only demonstrate impairments in attention but they also experience motor impairment. These individuals also have an imbalance in excitation in the brain. This study will examine the preliminary effects of non-invasive brain stimulation (transcranial direct current stimulation, tDCS) combined with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with neglect following stroke. The investigators will examine the effects of the intervention on brain excitability, upper extremity motor impairment, and attentional impairment. This study will also examine assessment of neglect. There are many clinical assessments designed to assess neglect; however, it is unknown whether items from some of the most commonly used assessments are able to effectively measure neglect or whether items from these assessments can be combined. Clinicians rely on clinical assessments to inform treatment and document patient progress. Therefore, it is important that investigators more closely examine these existing assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham transcranial direct current stimulation (tDCS) plus repetitive task-specific practice (RTP) | Sham comparator | Device: Sham transcranial direct current stimulation (tDCS)Single session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP) |
| Active tDCS plus RTP | Active comparator | Device: Active direct current stimulation (tDCS)Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- History of cortical hemorrhagic stroke
- Presence of any MRI, TMS, tDCS risk factors including:
- Severe spasticity (Modified Ashworth Scale score 3)
- Severe aphasia or cognitive impairment limiting participants' comprehension (National Institutes of Health Stroke Scale Level of Consciousness Commands Item score 1 or Best Language Item score 2)
- Unable to travel to UE Motor Function Laboratory at the Center for Rehabilitation Research in Neurological Conditions (a collaborative, Memorandum of Understanding (MOU) approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham transcranial direct current stimulation (tDCS)Also: noninvasive brain stimulation, transcranial direct current stimulationSham 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 | Device | Sham transcranial direct current stimulation (tDCS) plus repetitive task-specific practice (RTP) |
| Active direct current stimulation (tDCS)Also: noninvasive brain stimulation, transcranial direct current stimulationSham 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 | Device | Active tDCS plus RTP |
Primary outcome
Change in excitability of fronto-parietal connectivity
Time frame: Participants will be assessed at baseline and 30 minutes later
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.
2 secondary outcomes
Change in upper extremity kinematics
Time frame: Participants will be assessed at baseline and 30 minutes later
Change on Behavioral Inattention Test
Time frame: Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 34196963Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily S. Grattan, PhD MS BS principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active direct current stimulation (tDCS) in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily S Grattan, PhD MS BS ((412) 559-4920, ESG39@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in excitability of fronto-parietal connectivity (time frame: Participants will be assessed at baseline and 30 minutes later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.