StrokeNCT04574973
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
A study testing transcranial direct current stimulation and intensive upper extremity motor training in people with Stroke and Hemiparesis, run by University of Kentucky at 1 site in United States.
Trial summary
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- transcranial direct current stimulation and intensive upper extremity motor training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to 8 Jan 2021
- Phase
- Interventional
- 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
- 12 or more months post-stroke
- Inability to extend the affected metacarpophalangeal joints at least 10 degrees and the wrist 20 degrees
Who cannot join
- Addition or change in dosage of drugs known to exert detrimental effects on motor recovery within 3 month of enrollment
- Untreated depression
- History of multiple strokes
- History of head injury with loss of consciousness
- History of severe alcohol or drug abuse, or psychiatric illness
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
- Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain
- Cardiac or neural pacemakers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, 40504
About this study
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.
Read the detailed description
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of four groups by chance. Three groups will receive tDCS at a level expected to increase the brain's ability to change, and will vary by the areas of the brain that are stimulated. The fourth group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their impaired arm and hand, focusing on exercises that will improve their ability to function in daily life.
- Conditions
- Stroke, Hemiparesis
- Being tested
- transcranial direct current stimulation, intensive upper extremity motor training
- Keywords
- neuroplasticity, rehabilitation, transcranial direct current stimulation, motor training
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
intensive upper extremity motor trainingBehavioural
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. Receives: Device: transcranial direct current stimulation; Behavioral: intensive upper extremity motor training |
| Cathodal tDCS | Experimental | Subjects will receive 20 minutes of active, excitatoryinhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. Receives: Device: transcranial direct current stimulation; Behavioral: intensive upper extremity motor training |
| Dual tDCS | Experimental | Subjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere and inhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. Receives: Device: transcranial direct current stimulation; Behavioral: intensive upper extremity motor training |
| Sham tDCS | Sham comparator | Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity. Receives: Device: transcranial direct current stimulation; Behavioral: intensive upper extremity motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment from baseline
This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.
Measured: Baseline, Immediately post-intervention, one-month follow-up
Secondary outcomes (3)
Change in Action Research Arm Test from baseline
This consists of 4 tests to measure grasp, grip, pinch, and gross movement. An increase in score indicates an improvement in function.
Measured: Baseline, Immediately post-intervention, one-month follow-up
Change in Stroke Impact Scale from baseline
This is a self-report measure of 64 items that assess 8 domains, including strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. A score increase indicates an improvement.
Measured: Baseline, Immediately post-intervention, one-month follow-up
Change in cortical motor map from baseline
This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm.
Measured: Baseline, Immediately post-intervention, one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start28 Nov 2018
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Why it stopped: Relocation of PI
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lumy Sawaki, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574973
- Sponsor's protocol ID
- 47644
- Status last verified
- Jan 2021
- First submitted
- 28 Sep 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
- ClinicalTrials.gov ID
- NCT04574973
- Acronym / sponsor ID
- 47644
- Conditions
- Stroke, Hemiparesis
- Keywords
- neuroplasticity, rehabilitation, transcranial direct current stimulation, motor training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Relocation of PI
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 5 Oct 2020 (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.
Individuals who experienced a stroke over one year ago will be randomly assigned to receive 1 of 4 different conditions of brain stimulation. All individuals will receive therapy of the hand and arm following the stimulation. This study will try to determine which brain stimulation condition leads to the greatest improvement in hand and arm function.
Detailed description
This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of four groups by chance. Three groups will receive tDCS at a level expected to increase the brain's ability to change, and will vary by the areas of the brain that are stimulated. The fourth group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their impaired arm and hand, focusing on exercises that will improve their ability to function in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: transcranial direct current stimulation, Behavioral: intensive upper extremity motor trainingSubjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. |
| Cathodal tDCS | Experimental | Device: transcranial direct current stimulation, Behavioral: intensive upper extremity motor trainingSubjects will receive 20 minutes of active, excitatoryinhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. |
| Dual tDCS | Experimental | Device: transcranial direct current stimulation, Behavioral: intensive upper extremity motor trainingSubjects will receive 20 minutes of active, excitatory transcranial direct current stimulation of the ipsilesional hemisphere and inhibitory transcranial direct current stimulation of the contralesional hemisphere at 1.4mA, followed by 2 hours of intensive motor therapy of the affected upper extremity. |
| Sham tDCS | Sham comparator | Device: transcranial direct current stimulation, Behavioral: intensive upper extremity motor trainingSubjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the affected upper extremity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 12 or more months post-stroke
- Inability to extend the affected metacarpophalangeal joints at least 10 degrees and the wrist 20 degrees
Key exclusion criteria (8 listed)
- Addition or change in dosage of drugs known to exert detrimental effects on motor recovery within 3 month of enrollment
- Untreated depression
- History of multiple strokes
- History of head injury with loss of consciousness
- History of severe alcohol or drug abuse, or psychiatric illness
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 |
|---|---|---|
| transcranial direct current stimulationThis is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp. | Device | Anodal tDCS, Cathodal tDCS, Dual tDCS, Sham tDCS |
| intensive upper extremity motor trainingThis training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life. | Behavioural | Anodal tDCS, Cathodal tDCS, Dual tDCS, Sham tDCS |
Primary outcome
Change in Fugl-Meyer Assessment from baseline
Time frame: Baseline, Immediately post-intervention, one-month follow-up
This provides a quantitative measure of motor recovery, balance, sensation, coordination, and speed. An increase in score indicates an improvement in function.
3 secondary outcomes
Change in Action Research Arm Test from baseline
Time frame: Baseline, Immediately post-intervention, one-month follow-up
Change in Stroke Impact Scale from baseline
Time frame: Baseline, Immediately post-intervention, one-month follow-up
Change in cortical motor map from baseline
Time frame: Baseline, Immediately post-intervention, one-month follow-up
Results and safety
The study was stopped early (reason given: Relocation of PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation and intensive upper extremity motor training in people with Stroke and Hemiparesis, run by University of Kentucky 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 2 inclusion and 8 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 15 Jan 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.
Are results available for this study?
The study was stopped early (reason given: Relocation of PI). 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 Fugl-Meyer Assessment from baseline (time frame: Baseline, Immediately post-intervention, one-month follow-up). 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 15 Jan 2021.