StrokeT-NIBSNCT04058288
Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients
An observational study of Stroke, run by Kessler Foundation at 1 site in United States.
Trial summary
This study will investigate the use of High-definition Transcranial Direct Current Stimulation (HD-tDCS) in the functional improvement of hand dexterity while performing music-assisted hand exercises. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- High-definition Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 31 May 2023
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primarily, the stroke survivors from the New Jersey/New York City area. Although not restricted to any primary care clinic, we encourage participants from the Kessler Institute for Rehabilitation.
Who may be able to join
- Aged between 18-75 years
- Clinically diagnosed with hemiparetic stroke (weakness on one side - either left or right side of the body)
- Have had a stroke for more than 6 months
- Have weakness in moving the fingers of the affected hand
- Able to understand and perform the instructions that are part of the tDCS-MusicGlove testing and intervention.
- Willing and able to participate in and travel to Kessler Foundation for the screening session, MRI session, and tDCS-MusicGlove sessions.
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- Able to sit and be active for 1.5 hours during the session without cardiac, respiratory and/or pain disturbances as assessed during the screening visit.
- Able to provide informed consent.
- Medically stable and not planning for a major change in medications for at least 4 weeks
Who cannot join
- Unable to move the hand because of muscle stiffness (scoring 3 or more on the Ashworth scale)
- Have lost the sensation of hand movement
- Have a history of alcohol abuse and/or illicit drug use
- Have a history of smoking within the past 5 years
- Have a problem with the eyesight that would make it difficult to notice the changing instructions on a computer screen
- Currently enrolled in another research study that might affect this research study
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- A history of epilepsy (including family members who are diagnosed with epilepsy)
- An active history of migraine or chronic headache
- A history of mental illness (e.g. schizophrenia, anxiety, depression, and PTSD)
- Past or current history of treated ringing in the ears known as tinnitus or severe hearing problems
- Have a tattoo with metal-based ink in the head or neck.
- Have severe skin damage on the scalp
- Afraid of confined spaces (claustrophobic)
- Have metallic implants, including intracranial electrodes, surgical clips, shrapnel or a pacemaker.
- Currently taking medications that increase the risk of seizures
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Foundation
West Orange, New Jersey, 07052-1424
About this study
Official title: Targeted Noninvasive Brain Stimulation (T-NIBS) for Improving Hand Dexterity in Stroke Patients
This study will investigate the use of High-definition Transcranial Direct Current Stimulation (HD-tDCS) in the functional improvement of hand dexterity while performing music-assisted hand exercises.
Read the detailed description
Stroke is a serious medical and health problem in the US, and most of the stroke patients suffer from upper-limb motor deficits including weakened hand dexterity. As upper-limb motor functions are crucial for most of the daily living activities, there is a need for effective intervention. The current therapeutic approaches involve intensive physical therapy training involving repetitive tasks which causes fatigue and lack of engagement in the patients. To address this issue, the investigators will investigate the combined use of individually targeted noninvasive brain stimulation (T-NIBS) using High-definition Transcranial Direct Current Stimulation (HD-tDCS) and music-assisted hand exercises using MusicGlove to modulate the neuroplasticity in the desired manner to observe functional changes in hand dexterity.
- Conditions
- Stroke
- Being tested
- High-definition Transcranial Direct Current Stimulation
- Keywords
- stroke, HD-tDCS, musicglove, Upper-limb rehab
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-definition Transcranial Direct Current StimulationDevice
Stimulation sessions will be conducted on 2 different visits separated by 2-week gap. In a crossover design, Anodal HD-tDCS will be delivered either in Active/Sham mode (during the first visit) and Sham/Active during the second visit in a 4x1 ring configuration (center electrode being Anode and the surrounding 4 electrodes being cathodes) over the affected motor area.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | People suffering from upper-limb motor dysfunction due to stroke Receives: Device: High-definition Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Nine-Hole Peg Test (NHPT) scores
NHPT is a secondary outcome measure of finger dexterity that can be used in stroke patients with upper extremity motor deficits. It is considered to be a reliable measure of hand dexterity and recommended for inclusion in NIH toolbox Assessment of Neurological and Behavioral Function. NHPT requires participants to repeatedly place nine pegs into nine holes, one at a time, as quickly as possible and then remove them from the holes. The total time needed to complete the task is then recorded.
Measured: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
Changes in the Dexterity and Speed Test (DAST) scores
DAST is exclusively developed for MusicGlove performance assessment and it is designed to evaluate how fast and accurately do the subjects respond to the sequence of music notes that continuously sped up.
Measured: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
Secondary outcomes (1)
Changes in the Cortical Excitability using Motor Evoked Potentials (MEP)
MEP outcome measures have become the norm in brain stimulation studies. We hypothesize that the MEP amplitude and latency before- and after-intervention would reveal more information about the neuroplasticity changes during motor recovery. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% RMT).
Measured: baseline (at day 1), during testing visits (day 2 and day 3) - all within 2 weeks from the screening and consenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start28 Oct 2019
- Primary completion14 Feb 2022
- Study completion31 May 2023
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.
- More trials run by Kessler FoundationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vikram Shenoy Handiru, Kessler Foundation
- Investigators
- Guang Yue, PhD, Study director, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058288
- Sponsor's protocol ID
- R-1056-19
- Acronym
- T-NIBS
- Status last verified
- Jun 2023
- First submitted
- 29 Jul 2019
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Noninvasive Brain Stimulation (T-NIBS) for Improving Hand Dexterity in Stroke Patients
- ClinicalTrials.gov ID
- NCT04058288
- Acronym / sponsor ID
- T-NIBS / R-1056-19
- Conditions
- Stroke
- Keywords
- stroke, HD-tDCS, musicglove, Upper-limb rehab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 15 Aug 2019 (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 will investigate the use of High-definition Transcranial Direct Current Stimulation (HD-tDCS) in the functional improvement of hand dexterity while performing music-assisted hand exercises.
Detailed description
Stroke is a serious medical and health problem in the US, and most of the stroke patients suffer from upper-limb motor deficits including weakened hand dexterity. As upper-limb motor functions are crucial for most of the daily living activities, there is a need for effective intervention. The current therapeutic approaches involve intensive physical therapy training involving repetitive tasks which causes fatigue and lack of engagement in the patients. To address this issue, the investigators will investigate the combined use of individually targeted noninvasive brain stimulation (T-NIBS) using High-definition Transcranial Direct Current Stimulation (HD-tDCS) and music-assisted hand exercises using MusicGlove to modulate the neuroplasticity in the desired manner to observe functional changes in hand dexterity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Device: High-definition Transcranial Direct Current StimulationPeople suffering from upper-limb motor dysfunction due to stroke |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primarily, the stroke survivors from the New Jersey/New York City area. Although not restricted to any primary care clinic, we encourage participants from the Kessler Institute for Rehabilitation.
Key inclusion criteria (9 listed)
- Aged between 18-75 years
- Clinically diagnosed with hemiparetic stroke (weakness on one side - either left or right side of the body)
- Have had a stroke for more than 6 months
- Have weakness in moving the fingers of the affected hand
- Able to understand and perform the instructions that are part of the tDCS-MusicGlove testing and intervention.
Key exclusion criteria (16 listed)
- Unable to move the hand because of muscle stiffness (scoring 3 or more on the Ashworth scale)
- Have lost the sensation of hand movement
- Have a history of alcohol abuse and/or illicit drug use
- Have a history of smoking within the past 5 years
- Have a problem with the eyesight that would make it difficult to notice the changing instructions on a computer screen
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 |
|---|---|---|
| High-definition Transcranial Direct Current StimulationStimulation sessions will be conducted on 2 different visits separated by 2-week gap. In a crossover design, Anodal HD-tDCS will be delivered either in Active/Sham mode (during the first visit) and Sham/Active during the second visit in a 4x1 ring configuration (center electrode being Anode and the surrounding 4 electrodes being cathodes) over the affected motor area. | Device | Stroke |
Primary outcome
Changes in the Nine-Hole Peg Test (NHPT) scores
Time frame: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
NHPT is a secondary outcome measure of finger dexterity that can be used in stroke patients with upper extremity motor deficits. It is considered to be a reliable measure of hand dexterity and recommended for inclusion in NIH toolbox Assessment of Neurological and Behavioral Function. NHPT requires participants to repeatedly place nine pegs into nine holes, one at a time, as quickly as possible and then remove them from the holes. The total time needed to complete the task is then recorded.
Changes in the Dexterity and Speed Test (DAST) scores
Time frame: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
DAST is exclusively developed for MusicGlove performance assessment and it is designed to evaluate how fast and accurately do the subjects respond to the sequence of music notes that continuously sped up.
1 secondary outcome
Changes in the Cortical Excitability using Motor Evoked Potentials (MEP)
Time frame: baseline (at day 1), during testing visits (day 2 and day 3) - all within 2 weeks from the screening and consenting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
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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.
Guang Yue, PhD study director
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Kessler Foundation 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 9 inclusion and 16 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: finished, as of the sponsor's last update on 12 Jun 2023. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the Nine-Hole Peg Test (NHPT) scores (time frame: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting). The study lists 2 primary outcomes in all. 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 12 Jun 2023.