StrokeNCT04502290
Synchronized Brain and Hand Stimulation After Stroke
A study testing Combined Non-invasive brain stimulation and functional electrical hand stimulation in people with Stroke and Upper Extremity Paresis, run by Amit Sethi at 1 site in United States.
Trial summary
Among the 795,000 individuals who sustain a stroke annually in the United States, 65% continue to experience moderate-to-severe impairments in one hand six months or more, which limits their ability to perform daily tasks. Currently there is dearth of understanding of the mechanisms of motor recovery after stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Upper Extremity Paresis
- What is being tested?
- Combined Non-invasive brain stimulation and functional electrical hand stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 22 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (either right or left handed) with unilateral hemiparesis after stroke;
- Stroke onset of at least six months prior to the time of participation;
- Ability to elicit motor evoked potential in the Extensor digitorum communis (EDC) muscle
- Ability to grasp, as indicated by a score of at least 1 (out of 2) on the finger mass flexion and cylindrical grasp items of Upper Extremity Fugl-Meyer scale
- age between 18-80 years
Who cannot join
- Presence of severe aphasia , measured by cognitive and/or language impairments that preclude the ability to follow simple instructions;
- Excessive spasticity of wrist and finger muscles, defined as a Modified Ashworth Score more than or equal to 3, which may limit the ability to open the hand/fingers;
- Diagnosis of neurological disorders other than stroke, which may confound the results;
- Has touch and proprioceptive sensory deficits determined via a score of 0 on the position sense section (section H) of the Fugl Meyer Upper Extremity assessment proprioception, which may limit the ability to report excessive amount of tingling due to hand stimulation
- History of seizure or epilepsy as the effects of TMS are not tested in individuals with seizures or epilepsy;
- Orthopaedic/musculoskeletal conditions (eg, arthritis) affecting the upper extremity, which may limit the ability to move the affected hand
Show all 19Show fewer
- Presence of metallic implants in the head or neck for TMS;
- Currently or planning to become pregnant, as the effects of TMS are not tested not pregnant women;
- Difficulty maintaining alertness or remaining still for MRI;
- Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for MRI);
- Bodyweight > 300 lbs due to MRI scanner dimensions
- Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic medication, which may confound the results
- Cognitive impairments, defined as a score of < 23 on the Mini Mental Status Examination, which may limit the ability to follow the commands in the study
- Excessive pain > equal to 5 on Visual Analog Scale in the more-affected upper extremity, which may limit the ability to participate in the study
- History of schizophrenia, Bipolar disorder (type I or II) [Answer yes to questions 16 and items of the (hypo) maniac module of the The Mini International Neuropsychiatric Interview], current moderate, severe depression (Scores of >10 on Patient Health Questionnaire-9) and other neurological or medical conditions that could confound results.
- Life expectancy less than the duration of the study
- Hemispatial neglect, which may limit the ability to pay attention to the affected hand
- Participating in concurrent therapy, which may confound the results
- We will exclude children because although stroke may occur in children, the protocol is addressing stoke in adults and the devices are not approved for use in children
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuromotor Recovery and Rehabilitation Lab
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Synchronized Brain and Hand Stimulation to Improve Hand Function After Stroke
Among the 795,000 individuals who sustain a stroke annually in the United States, 65% continue to experience moderate-to-severe impairments in one hand six months or more, which limits their ability to perform daily tasks. Currently there is dearth of understanding of the mechanisms of motor recovery after stroke. Understanding the mechanisms can potentially lead to the development of interventions to improve motor performance after stroke. The proposed study will examine how synchronously pairing brain and hand stimulation repeatedly affects the plasticity of the brain and motor performance after stroke. The knowledge gained from this study can be useful to develop interventions to improve hand movement after moderate-severe stroke.
- Conditions
- Stroke, Upper Extremity Paresis
- Being tested
- Combined Non-invasive brain stimulation and functional electrical hand stimulation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Non-invasive brain stimulation and functional electrical hand stimulationDevice
Participants will receive synchronously combined non-invasive brain stimulation (delivered via electrical/magnetic stimulation) with functional electrical stimulation (delivered via DS7A or Neuromove) of the weak hand
| Study group | Role | What they receive |
|---|---|---|
| Combined non-invasive brain and Functional Electrical Stimulation | Experimental | In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES Receives: Device: Combined Non-invasive brain stimulation and functional electrical hand stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Box and Block Test
The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the participants to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box is oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. Participants first perform this test with their unaffected hand in order to practice and register baseline scores. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to participants are advised that their fingertips must cross the partition when
Measured: Baseline to 6 weeks
Secondary outcomes (2)
Percent Change in Motor Evoked Potential
Surface EMG electrodes (Ag-AgCl) will be applied to the belly of the affected EDC muscle and a reference electrode will be placed at the clavicle. The motor evoked potential (MEP) data will be collected by stimulating the targets in the grid at 2000 Hz with Signal software (CED, Cambridge, UK). The raw values are measured in mili volts, but we report as a percent change compared to the pre-intervention or baseline.
Measured: Baseline to 6 weeks
Average Percent Change in Hand Force
We will measure force production of the combined wrist and finger extensors (EDC) using two 34.09 kg load cells embedded in cushioned customized platforms. The height of the load cells can be altered to accommodate individual hand sizes. Participants will perform 5 trials of combined isometric wrist and finger extension movements against load cells for 10 seconds. The force data will be amplified by 5-20K and collected at 1000 Hz using Biopac amplifier and software (Biopac Systems Inc, Goleta, CA, USA). To allow for the deliberate increase to peak force as well as the tendency to drop off near the end of the 10-second interval, we will calculate the combined wrist and finger extension force output over the central 5 second segment. We will average the force across 5 trials. The raw values are measured in kilograms force, but we report as an average percent change compared to the pre-intervention or baseline.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Oct 2020
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amit Sethi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amit Sethi, University of Pittsburgh
- Investigators
- Amit Sethi, Principal investigator, UPitt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502290
- Sponsor's protocol ID
- STUDY19070157
- Status last verified
- Jul 2025
- First submitted
- 3 Aug 2020
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchronized Brain and Hand Stimulation to Improve Hand Function After Stroke
- ClinicalTrials.gov ID
- NCT04502290
- Acronym / sponsor ID
- STUDY19070157
- Conditions
- Stroke, Upper Extremity Paresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Amit SethiUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among the 795,000 individuals who sustain a stroke annually in the United States, 65% continue to experience moderate-to-severe impairments in one hand six months or more, which limits their ability to perform daily tasks. Currently there is dearth of understanding of the mechanisms of motor recovery after stroke. Understanding the mechanisms can potentially lead to the development of interventions to improve motor performance after stroke. The proposed study will examine how synchronously pairing brain and hand stimulation repeatedly affects the plasticity of the brain and motor performance after stroke. The knowledge gained from this study can be useful to develop interventions to improve hand movement after moderate-severe stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined non-invasive brain and Functional Electrical Stimulation | Experimental | Device: Combined Non-invasive brain stimulation and functional electrical hand stimulationIn this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female (either right or left handed) with unilateral hemiparesis after stroke;
- Stroke onset of at least six months prior to the time of participation;
- Ability to elicit motor evoked potential in the Extensor digitorum communis (EDC) muscle
- Ability to grasp, as indicated by a score of at least 1 (out of 2) on the finger mass flexion and cylindrical grasp items of Upper Extremity Fugl-Meyer scale
- age between 18-80 years
Key exclusion criteria (19 listed)
- Presence of severe aphasia , measured by cognitive and/or language impairments that preclude the ability to follow simple instructions;
- Excessive spasticity of wrist and finger muscles, defined as a Modified Ashworth Score more than or equal to 3, which may limit the ability to open the hand/fingers;
- Diagnosis of neurological disorders other than stroke, which may confound the results;
- Has touch and proprioceptive sensory deficits determined via a score of 0 on the position sense section (section H) of the Fugl Meyer Upper Extremity assessment proprioception, which may limit the ability to report excessive amount of tingling due to hand stimulation
- History of seizure or epilepsy as the effects of TMS are not tested in individuals with seizures or epilepsy;
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 |
|---|---|---|
| Combined Non-invasive brain stimulation and functional electrical hand stimulationParticipants will receive synchronously combined non-invasive brain stimulation (delivered via electrical/magnetic stimulation) with functional electrical stimulation (delivered via DS7A or Neuromove) of the weak hand | Device | Combined non-invasive brain and Functional Electrical Stimulation |
Primary outcome
Percent Change in Box and Block Test
Time frame: Baseline to 6 weeks
The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the participants to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box is oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. Participants first perform this test with their unaffected hand in order to practice and register baseline scores. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to participants are advised that their fingertips must cross the partition when
2 secondary outcomes
Percent Change in Motor Evoked Potential
Time frame: Baseline to 6 weeks
Average Percent Change in Hand Force
Time frame: Baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Amit Sethi principal investigator
UPitt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Non-invasive brain stimulation and functional electrical hand stimulation in people with Stroke and Upper Extremity Paresis, run by Amit Sethi 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 19 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 15 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Box and Block Test (time frame: Baseline to 6 weeks). 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 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.