StrokePhase 1NCT02892097
Transcranial Direct Current Stimulation (tDCS) and Task-Specific Practice for Post-stroke Neglect
A Phase 1 study testing tDCS and Repetitive task-specific practice (RTP) in people with Stroke and Hemispatial Neglect, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of three different rehabilitation training sessions that combine non-invasive brain stimulation (transcranial direct current stimulation, tDCS) with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with unilateral spatial neglect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemispatial Neglect
- What is being tested?
- tDCS and Repetitive task-specific practice (RTP)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 7 Nov 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Unilateral hemispheric ischemic stroke or hemorrhagic subcortical stroke ≥3 months post stroke (lesion type and location to be confirmed with MRI)
- Neglect (Virtual Reality Lateralized Attention Test score <18)
- Upper extremity Fugl-Meyer score between 20-56/60
- Inducible motor evoked potential (MEP) of the abductor pollicis brevis (APB) on the affected side using transcranial magnetic stimulation (TMS)
- ≥18 years old
Who cannot join
- History of cortical hemorrhagic stroke
- Severe spasticity (Modified Ashworth Scale score ≥3) in paretic upper extremity
- Severe aphasia limiting participant's ability to follow 2 step directions
- History of seizures
- History of brain tumor
- History of skull defect
Show all 12Show fewer
- Hardware in skull or spine (e.g. coils, clips)
- Implantable medical device (e.g. pacemaker)
- Metal in body that is not compatible with MRI
- Pregnant (women of child bearing age will be asked if they are pregnant or could possibly be pregnant)
- Unable to travel to Upper Extremity Motor Function Laboratory at the Center for Rehabilitation Research in Neurological Conditions
- Currently enrolled in another study using transcranial direct current stimulation (tDCS) or transcranial magnetic stimulation (TMS)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Examining the Effects of Transcranial Direct Current Stimulation and Task-specific Practice on Cortical Modulation Among Individuals With Unilateral Spatial Neglect Post Stroke
The purpose of this study is to test the effects of three different rehabilitation training sessions that combine non-invasive brain stimulation (transcranial direct current stimulation, tDCS) with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with unilateral spatial neglect following stroke. This study is designed to determine the effects of tDCS + RTP on the excitability in the brain, attention to the affected side, and arm movement ability.
Read the detailed description
Unilateral neglect (neglect) is common after stroke and is characterized by an inattention to one side of the body or environment. There is growing evidence that disconnections to fronto-parietal neural networks in the lesioned hemisphere not only cause neglect, but also cause these same networks to be hyperexcited in the non-lesioned hemisphere. Individuals with neglect typically experience motor impairments also since the regions of the brain that control attention also control movement.
Transcranial direct current stimulation (tDCS) when paired with repetitive task-specific practice (RTP) has the potential to modulate cortical activity (fronto-parietal networks) and facilitate motor and attentional recovery for individuals with neglect since tDCS can modulate the excitability of targeted cortical regions. tDCS is a form on non-invasive brain stimulation and RTP is the gold standard post-stroke motor recovery intervention.
It is particularly important investigators examine the effect of RTP + tDCS on cortical modulation in order to understand the underlying mechanism of the intervention and determine whether RTP+ tDCS (parietal or primary motor cortex [M1]) promotes greater neural modulation than RTP alone. Traditionally, electrodes are placed on M1 to facilitate motor recovery and on the parietal lobe to facilitate attentional recovery, however this intervention is designed to target each of these impairments (motor, attention) and enhance cortical modulation of fronto-parietal networks. Therefore, investigators must also determine the optimal electrode montage and placement for pairing tDCS with RTP for individuals with neglect.
The purpose of the proposed pilot project is to examine the effects of transcranial direct current stimulation (tDCS) paired with repetitive task-specific practice (RTP) on modulation of fronto-parietal network connectivity (measured by transcranial magnetic stimulation [TMS]), motor impairment (measured with kinematic assessment), and attentional impairment (measured with Behavioral Inattention Test) among individuals with unilateral neglect and hemiparesis post stroke. This three day cross-over design study will examine the optimal electrode placement and montage using 3 conditions: (1) tDCS to parietal lobe + RTP (2) tDCS to primary motor cortex + RTP (3) sham tDCS + RTP.
- Conditions
- Stroke, Hemispatial Neglect
- Being tested
- tDCS, sham tDCS, Repetitive task-specific practice (RTP)
- Keywords
- tDCS, neglect, paresis, transcranial direct current stimulation, rehabilitation
- Medical subject headings
- Stroke, Perceptual Disorders, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called noninvasive brain stimulation, transcranial direct current stimulation
tDCS is a form of noninvasive brain stimulation. Electrodes are placed on the scalp (parietal or primary motor cortex) and deliver a low level of direct current (2mA). tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.
sham tDCSDevice
Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.
Repetitive task-specific practice (RTP)Behavioural
Also called task practice
Participants will practice using their paretic arm/hand to complete functional movements during each (3) 30 minute training session.
| Study group | Role | What they receive |
|---|---|---|
| Parietal tDCS plus RTP | Active comparator | Single session of bilateral parietal tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP). Receives: Device: tDCS; Behavioral: Repetitive task-specific practice (RTP) |
| Primary motor cortex tDCS plus RTP | Active comparator | Single session of bilateral primary motor cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP) Receives: Device: tDCS; Behavioral: Repetitive task-specific practice (RTP) |
| Sham tDCS plus RTP | Sham comparator | Single session of sham tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP) Receives: Device: sham tDCS; Behavioral: Repetitive task-specific practice (RTP) |
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 (immediately following intervention session).
Secondary outcomes (2)
Change in kinematics
A kinematic assessment will be conducted to assess changes in motor impairment.
Measured: Participants will be assessed at baseline and 1 hour later (immediately following intervention session).
Change on Behavioral Inattention Test
A neglect assessment will be conducted to assess changes in attentional impairment.
Measured: Participants will be assessed at baseline and 1.5 hours later (immediately following intervention session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Why it stopped: Enrolled 1 participant, PI left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Emily Grattan, PhD, OTR/L, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892097
- Sponsor's protocol ID
- PRO00056688
- Other IDs
- P2CHD086844
- Status last verified
- Sep 2021
- First submitted
- 10 Aug 2016
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Transcranial Direct Current Stimulation and Task-specific Practice on Cortical Modulation Among Individuals With Unilateral Spatial Neglect Post Stroke
- ClinicalTrials.gov ID
- NCT02892097
- Acronym / sponsor ID
- PRO00056688
- Conditions
- Stroke, Hemispatial Neglect
- Keywords
- tDCS, neglect, paresis, transcranial direct current stimulation, rehabilitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolled 1 participant, PI left the institution.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2016 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
The purpose of this study is to test the effects of three different rehabilitation training sessions that combine non-invasive brain stimulation (transcranial direct current stimulation, tDCS) with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with unilateral spatial neglect following stroke. This study is designed to determine the effects of tDCS + RTP on the excitability in the brain, attention to the affected side, and arm movement ability.
Detailed description
Unilateral neglect (neglect) is common after stroke and is characterized by an inattention to one side of the body or environment. There is growing evidence that disconnections to fronto-parietal neural networks in the lesioned hemisphere not only cause neglect, but also cause these same networks to be hyperexcited in the non-lesioned hemisphere. Individuals with neglect typically experience motor impairments also since the regions of the brain that control attention also control movement.
Transcranial direct current stimulation (tDCS) when paired with repetitive task-specific practice (RTP) has the potential to modulate cortical activity (fronto-parietal networks) and facilitate motor and attentional recovery for individuals with neglect since tDCS can modulate the excitability of targeted cortical regions. tDCS is a form on non-invasive brain stimulation and RTP is the gold standard post-stroke motor recovery intervention.
It is particularly important investigators examine the effect of RTP + tDCS on cortical modulation in order to understand the underlying mechanism of the intervention and determine whether RTP+ tDCS (parietal or primary motor cortex [M1]) promotes greater neural modulation than RTP alone. Traditionally, electrodes are placed on M1 to facilitate motor recovery and on the parietal lobe to facilitate attentional recovery, however this intervention is designed to target each of these impairments (motor, attention) and enhance cortical modulation of fronto-parietal networks. Therefore, investigators must also determine the optimal electrode montage and placement for pairing tDCS with RTP for individuals with neglect.
The purpose of the proposed pilot project is to examine the effects of transcranial direct current stimulation (tDCS) paired with repetitive task-specific practice (RTP) on modulation of fronto-parietal network connectivity (measured by transcranial magnetic stimulation [TMS]), motor impairment (measured with kinematic assessment), and attentional impairment (measured with Behavioral Inattention Test) among individuals with unilateral neglect and hemiparesis post stroke. This three day cross-over design study will examine the optimal electrode placement and montage using 3 conditions: (1) tDCS to parietal lobe + RTP (2) tDCS to primary motor cortex + RTP (3) sham tDCS + RTP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parietal tDCS plus RTP | Active comparator | Device: tDCS, Behavioral: Repetitive task-specific practice (RTP)Single session of bilateral parietal tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP). |
| Primary motor cortex tDCS plus RTP | Active comparator | Device: tDCS, Behavioral: Repetitive task-specific practice (RTP)Single session of bilateral primary motor cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP) |
| Sham tDCS plus RTP | Sham comparator | Device: sham tDCS, Behavioral: Repetitive task-specific practice (RTP)Single session of sham tDCS (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 (5 listed)
- Unilateral hemispheric ischemic stroke or hemorrhagic subcortical stroke ≥3 months post stroke (lesion type and location to be confirmed with MRI)
- Neglect (Virtual Reality Lateralized Attention Test score <18)
- Upper extremity Fugl-Meyer score between 20-56/60
- Inducible motor evoked potential (MEP) of the abductor pollicis brevis (APB) on the affected side using transcranial magnetic stimulation (TMS)
- ≥18 years old
Key exclusion criteria (12 listed)
- History of cortical hemorrhagic stroke
- Severe spasticity (Modified Ashworth Scale score ≥3) in paretic upper extremity
- Severe aphasia limiting participant's ability to follow 2 step directions
- History of seizures
- History of brain tumor
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 |
|---|---|---|
| tDCSAlso: noninvasive brain stimulation, transcranial direct current stimulationtDCS is a form of noninvasive brain stimulation. Electrodes are placed on the scalp (parietal or primary motor cortex) and deliver a low level of direct current (2mA). tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. | Device | Parietal tDCS plus RTP, Primary motor cortex tDCS plus RTP |
| sham tDCSSham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. | Device | Sham tDCS plus RTP |
| Repetitive task-specific practice (RTP)Also: task practiceParticipants will practice using their paretic arm/hand to complete functional movements during each (3) 30 minute training session. | Behavioural | Parietal tDCS plus RTP, Primary motor cortex tDCS plus RTP, Sham tDCS plus RTP |
Primary outcome
Change in excitability of fronto-parietal connectivity
Time frame: Participants will be assessed at baseline and 30 minutes later (immediately following intervention session).
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 kinematics
Time frame: Participants will be assessed at baseline and 1 hour later (immediately following intervention session).
Change on Behavioral Inattention Test
Time frame: Participants will be assessed at baseline and 1.5 hours later (immediately following intervention session).
Results and safety
The study was stopped early (reason given: Enrolled 1 participant, PI left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- 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. This study is not recruiting at the moment.
Emily Grattan, PhD, OTR/L principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tDCS and Repetitive task-specific practice (RTP) in people with Stroke and Hemispatial Neglect, run by Medical University of South Carolina 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 13 Sep 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrolled 1 participant, PI left the institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 (immediately following intervention session).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2021.