StrokeNCT05489146
t-RNS After Hand Recovery in Chronic Stroke
A study testing transcranial random noise stimulation and functional electrical stimulation facilitated task practice in people with Stroke, run by Amit Sethi at 1 site in United States.
Trial summary
Upper extremity (UE) paresis or weakness is one of the most frequent impairments after stroke. Despite intense rehabilitation, motor and functional recovery of patients with severe hand impairments is poor. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- transcranial random noise stimulation and functional electrical stimulation facilitated task practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2015to 15 Mar 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Episode (1 or more than one) of stroke at least 6 months prior
- Able to follow 3-step commands to rule out severe aphasia
- Unilateral hemiparesis
- Able to speak english
- No active drug or alcohol abuse, schizophrenia, other neurological or medical conditions that would confound results, or refractory depression
- Able to actively flex and extend the more-affected shoulder and elbow at least 30°.
- Able to elicit motor evoked potential in the flexor carpii radialis and extensor carpii radialis muscles of the affected hand.
Who cannot join
- Spasticity greater than equal to 2 on the Modified Ashworth Scale in shoulder, elbow, wrist and finger joints of the more-affected upper extremity
- Scores > 3 on the Amount scale of Motor Activity Log indicating good use of the more-affected hand
- Has ataxia determined via finger-to-nose testing section of the Fugl Meyer Upper Extremity assessment
- Has proprioceptive sensory deficits determined via a score of 2 on the position sense section (section H) of the Fugl Meyer Upper Extremity assessment proprioception
- Excessive pain > equal to 4 on Visual Analog Scale in the more-affected upper extremity
- Skin lesions on the more-affected upper extremity and scalp
Show all 15Show fewer
- Individuals with implanted devices that may be affected by electrical stimulation
- Participating in concurrent therapy
- Individuals with seizures
- History of seizures, schizophrenia, Bipolar disorder (type I or II) [Answer yes to questions 16 and items of the (hypo) maniac module of MINI], current moderate, severe depression (Scores of >10 on PHQ-9) and other neurological or medical conditions that could confound results.
- Individuals with refractory depression, which are defined as individuals with severe depressive disorder that are resistant to antidepressants (Scores of >10 on PHQ-9).
- Current treatment with antipsychotics or benzodiazepines.
- Current treatment with bupropion, which may induce seizure.
- Scores < 24 on Mini Mental Status Examination
- Pregnant women
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: Combining Transcranial Random Noise Stimulation and Functional Electrical Stimulation to Enhance Hand Function in Individuals With Chronic Stroke
Upper extremity (UE) paresis or weakness is one of the most frequent impairments after stroke. Despite intense rehabilitation, motor and functional recovery of patients with severe hand impairments is poor. Hence, there is a need for more effective treatments to enhance motor function in patients with severe hand impairments after stroke. Adaptive functional electrical stimulation (FES) appears to be a promising treatment and has the potential to facilitate active movement in individuals with severe impairments post-stroke. In addition, transcranial random noise stimulation (trns) is a widely studied, non-invasive and safe method to enhance the corticomotor excitability in individuals with chronic stroke. However, the effect of combining trns and adaptive FES in patients with severe hand impairments has not been investigated. Therefore, the purpose of this study is to investigate whether combining trns with FES will enhance hand function in individuals with chronic stroke than FES alone. The investigators predict that combining trns with FES will significantly enhance hand function than FES alone.
Read the detailed description
The primary purpose of this study was to investigate whether combining transcranial random noise stimulation with functional electrical stimulation-facilitated task practice will enhance hand function in individuals with severe paresis post-stroke than functional electrical stimulation alone.
The study is an experimental randomized study comparing the effects of transcranial random noise stimulation with functional electrical stimulation to functional electrical stimulation alone on recovery of function in the more-affected hand in individuals with chronic stroke.
Participants were randomized to receive transcranial random noise stimulation and functional electrical stimulation-facilitated task practice or sham-transcranial random noise stimulation and functional electrical stimulation-facilitated task practice.
Participants received 18 treatment sessions over 6 weeks (3 times/week for 6 weeks).
- Conditions
- Stroke
- Being tested
- transcranial random noise stimulation and functional electrical stimulation facilitated task practice
- Keywords
- stroke, hand, brain stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial random noise stimulation and functional electrical stimulation facilitated task practiceDevice
Participants were randomized to one of the two intervention groups [transcranial current stimulation (tRNS) and functional electrical stimulation (FES) or FES with sham tRNS] before pre-intervention testing. After randomization, participants underwent pre-intervention testing, followed by intervention 3 times per week for 6 weeks. Each intervention session lasted for 1 hour, where tRNS or sham-tRNS were delivered concurrently with the FES-facilitated task practice. tRNS or sham-tRNS was delivered for the first 30 minutes. Both tRNS and sham tRNS were delivered by the Starstim system. FES was delivered using the Neuromove system. All participants were treated by a licensed occupational therapist, who was trained on a manualized protocol.
| Study group | Role | What they receive |
|---|---|---|
| tRNS and FES facilitated task practice | Active comparator | In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice Receives: Device: transcranial random noise stimulation and functional electrical stimulation facilitated task practice |
| sham tRNS and FES facilitated task practice | Sham comparator | In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice Receives: Device: transcranial random noise stimulation and functional electrical stimulation facilitated task practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Fugl Meyer Upper Extremity Scale at Post Treatment
Fugl Meyer Upper Extremity Scale (FMUE) is considered the gold standard in upper extremity rehabilitation trials and measures upper extremity motor control by asking the participant to perform various arm and hand motions. Items are scored on a 3-point ordinal scale with 0 representing inability to complete the item and 2 representing the ability to complete the item as asked. We will use the total score, which ranges from 0-66. Higher score suggest better upper extremity motor control. The FMUE has been shown to have good reliability and validity.
Measured: Baseline, 6 weeks.
Change From Baseline in Fugl Meyer Upper Extremity Scale at 3 Months Post Treatment
Fugl Meyer Upper Extremity Scale (FMUE) is considered the gold standard in upper extremity rehabilitation trials and measures upper extremity motor control by asking the participant to perform various arm and hand motions. Items are scored on a 3-point ordinal scale with 0 representing inability to complete the item and 2 representing the ability to complete the item as asked. We will use the total score, which ranges from 0-66. Higher score suggest better upper extremity motor control. The FMUE has been shown to have good reliability and validity.
Measured: Baseline, 3 months.
Secondary outcomes (18)
Change From Baseline in Wolf Motor Function Test at Post Treatment
The Wolf Motor Function Test (WMFT) is a 15-item test in which participants are given 2 minutes to complete each item. The items increase in difficulty from simple UE movements requiring few degrees of freedom (e.g. placing hand on a table) to tasks requiring the coordination of many degrees of freedom of movement (e.g. folding a towel). We used average time taken to complete the 15-items. Faster performance is indicative of better task performance. The WMFT is a valid and reliable test of UE function post-stroke.
Measured: Baseline, 6 weeks.
Change From Baseline in Wolf Motor Function Test at 3 Months Post Treatment
The Wolf Motor Function Test (WMFT) is a 15-item test in which participants are given 2 minutes to complete each item. The items increase in difficulty from simple UE movements requiring few degrees of freedom (e.g. placing hand on a table) to tasks requiring the coordination of many degrees of freedom of movement (e.g. folding a towel). We used average time taken to complete the 15-items. Faster performance is indicative of better task performance. The WMFT is a valid and reliable test of UE function post-stroke.
Measured: Baseline, 3 months.
Change From Baseline in Grip Strength at Post Treatment
Grip strength measures the amount of maximum voluntary grip force of the weak hand using a hand-held dynamometer. We will use the maximum amount of force in pounds.
Measured: Baseline, 6 weeks.
Change From Baseline in Grip Strength at 3 Months Post Treatment
Grip strength measures the amount of maximum voluntary grip force of the weak hand using a hand-held dynamometer. We will use the maximum amount of force in pounds.
Measured: Baseline, 3 months.
Change From Baseline in Hand Subscale of Stroke Impact Scale at Post Treatment
The Hand sub scale of Stroke Impact Scale 3.0 (HSIS) will be used to measure the impact of stroke on participants' health and daily life. The Hand sub scale SIS is a self-report measure, which evaluates the ability of the hand to participate in daily tasks. The scale consists of 5 items and each item is scored on a 5-item Likert scale. We will use the total score, which ranges from 1-25, with a higher score indicative of better recovery.
Measured: Baseline, 6 weeks.
Change From Baseline in Hand Subscale of Stroke Impact Scale at 3 Months Post Treatment
The Hand sub scale of Stroke Impact Scale 3.0 (HSIS) will be used to measure the impact of stroke on participants' health and daily life. The Hand sub scale SIS is a self-report measure, which evaluates the ability of the hand to participate in daily tasks. The scale consists of 5 items and each item is scored on a 5-item Likert scale. We will use the total score, which ranges from 1-25, with a higher score indicative of better recovery.
Measured: Baseline, 3 months.
Change From Baseline in Action Research Arm Test at Post Treatment
Action Research Arm Test (ARAT) measures arm and hand recovery after stroke. The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score from the 4 sub-tests ranges from 0-57. We will use total score. Higher scores suggest better ability to grasp, grip and perform arm movements.
Measured: Baseline, 6 weeks.
Change From Baseline in Action Research Arm Test at 3 Months Post Treatment
Action Research Arm Test (ARAT) measures arm and hand recovery after stroke. The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score from the 4 sub-tests ranges from 0-57. We will use total score. Higher scores suggest better ability to grasp, grip and perform arm movements.
Measured: Baseline, 3 months.
Change in Baseline in H-reflex at Post Treatment
H-reflex testing will be used to record the spastic reflex in the Flexor carper radials (FCR) muscle of the weak hand. H-reflex is the reflex reaction of the muscles after electrical stimulation of the peripheral nerves supplying the muscle. Here we will stimulate the median nerve to stimulate and record the H-reflex values of the H-reflex. Normalized H-reflex values will be used. Lower values represent decrease in spasticity in the FCR after treatment.
Measured: Baseline, 6 weeks.
Change in Baseline in H-reflex at 3 Months Post Treatment
H-reflex testing will be used to record the spastic reflex in the Flexor carper radials (FCR) muscle of the weak hand. H-reflex is the reflex reaction of the muscles after electrical stimulation of the peripheral nerves supplying the muscle. Here we will stimulate the median nerve to stimulate and record the H-reflex values of the H-reflex. Normalized H-reflex values will be used. Lower values represent decrease in spasticity in the FCR after treatment.
Measured: Baseline, 3 weeks.
Change in Baseline in Brain Activity at Post Treatment
Electroencephalography (EEG) will be used to record brain activity. EEG will be recorded while the participant is attempting to perform movements of the weak hand, or while they are at rest. We will attach EEG sensors to the scalp to measure brain activity. We will compute power of the EEG signal in the alpha and beta bands. Higher values will represent increase in brain activity post treatment.
Measured: Baseline, 6 weeks.
Change in Baseline in Brain Activity at 3 Months Post Treatment
Electroencephalography (EEG) will be used to record brain activity. EEG will be recorded while the participant is attempting to perform movements of the weak hand, or while they are at rest. We will attach EEG sensors to the scalp to measure brain activity. We will compute power of the EEG signal in the alpha and beta bands. Higher values will represent increase in brain activity post treatment.
Measured: Baseline, 3 months.
Change in Baseline in Muscle Activity at Post Treatment
We will record muscle activity using Electromyography (EMG). We will collect EMG using 2 methods: basic EMG and High Definition EMG. In the basic EMG we will use (2 sensors) for the extensor carpi radials and flexor carp radials muscles and record muscle activity during wrist movements. In the High Definition EMG participants will wear a forearm sleeve, which will allows us to collect activity from multiple muscles, responsible for grasping and releasing objects of daily use. We will calculate the max voluntary contraction of the forearm muscles. Normalized values will be used. Higher values will represent increased muscle activity post treatment.
Measured: Baseline, 6 weeks.
Change in Baseline in Muscle Activity at 3 Months Post Treatment
We will record muscle activity using Electromyography (EMG). We will collect EMG using 2 methods: basic EMG and High Definition EMG. In the basic EMG we will use (2 sensors) for the extensor carpi radials and flexor carp radials muscles and record muscle activity during wrist movements. In the High Definition EMG participants will wear a forearm sleeve, which will allows us to collect activity from multiple muscles, responsible for grasping and releasing objects of daily use. We will calculate the max voluntary contraction of the forearm muscles. Normalized values will be used. Higher values will represent increased muscle activity post treatment.
Measured: Baseline, 3 months.
Change in Baseline in Brain Excitability at Post Treatment
We will use Transcranial Magnetic Stimulation (TMS) to measures the excitability of motor pathways in the brain. Normalized values will used. Higher values represent higher brain excitability post treatment.
Measured: Baseline, 6 weeks.
Change in Baseline in Brain Excitability at 3 Months Post Treatment
We will use Transcranial Magnetic Stimulation (TMS) to measures the excitability of motor pathways in the brain. Normalized values will used. Higher values represent higher brain excitability post treatment.
Measured: Baseline, 3 months.
Change in in Baseline in Upper Extremity Kinematics at Post Treatment
We will use motion capture system to measure changes in upper extremity kinematics, including shoulder, elbow, wrist joint range of motion. The values will be measured in degrees. Higher values will represent greater range of motion post treatment.
Measured: Baseline, 6 weeks.
Change in in Baseline in Upper Extremity Kinematics at 3 Months Post Treatment
We will use motion capture system to measure changes in upper extremity kinematics, including shoulder, elbow, wrist joint range of motion. The values will be measured in degrees. Higher values will represent greater range of motion post treatment.
Measured: Baseline, 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start15 Jan 2015
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amit Sethi
- Sponsor type
- University, hospital or other
- Collaborators
- Zynex Medical, Inc., Neuroelectrics Corporation
- Responsible party
- Sponsor-investigator, Amit Sethi, University of Pittsburgh
- Investigators
- Amit Sethi, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489146
- Sponsor's protocol ID
- PRO13090080
- Status last verified
- Dec 2022
- First submitted
- 22 Jul 2022
- Last updated
- 28 Dec 2022
- 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 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Transcranial Random Noise Stimulation and Functional Electrical Stimulation to Enhance Hand Function in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT05489146
- Acronym / sponsor ID
- PRO13090080
- Conditions
- Stroke
- Keywords
- stroke, hand, brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Amit SethiUniversity, hospital or other
- Collaborators
- Zynex Medical, Inc., Neuroelectrics Corporation
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Posted 28 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper extremity (UE) paresis or weakness is one of the most frequent impairments after stroke. Despite intense rehabilitation, motor and functional recovery of patients with severe hand impairments is poor. Hence, there is a need for more effective treatments to enhance motor function in patients with severe hand impairments after stroke. Adaptive functional electrical stimulation (FES) appears to be a promising treatment and has the potential to facilitate active movement in individuals with severe impairments post-stroke. In addition, transcranial random noise stimulation (trns) is a widely studied, non-invasive and safe method to enhance the corticomotor excitability in individuals with chronic stroke. However, the effect of combining trns and adaptive FES in patients with severe hand impairments has not been investigated. Therefore, the purpose of this study is to investigate whether combining trns with FES will enhance hand function in individuals with chronic stroke than FES alone. The investigators predict that combining trns with FES will significantly enhance hand function than FES alone.
Detailed description
The primary purpose of this study was to investigate whether combining transcranial random noise stimulation with functional electrical stimulation-facilitated task practice will enhance hand function in individuals with severe paresis post-stroke than functional electrical stimulation alone.
The study is an experimental randomized study comparing the effects of transcranial random noise stimulation with functional electrical stimulation to functional electrical stimulation alone on recovery of function in the more-affected hand in individuals with chronic stroke.
Participants were randomized to receive transcranial random noise stimulation and functional electrical stimulation-facilitated task practice or sham-transcranial random noise stimulation and functional electrical stimulation-facilitated task practice.
Participants received 18 treatment sessions over 6 weeks (3 times/week for 6 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tRNS and FES facilitated task practice | Active comparator | Device: transcranial random noise stimulation and functional electrical stimulation facilitated task practiceIn this arm, participants received real transcranial random noise stimulation with FES facilitated task practice |
| sham tRNS and FES facilitated task practice | Sham comparator | Device: transcranial random noise stimulation and functional electrical stimulation facilitated task practiceIn this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 or older
- Episode (1 or more than one) of stroke at least 6 months prior
- Able to follow 3-step commands to rule out severe aphasia
- Unilateral hemiparesis
- Able to speak english
Key exclusion criteria (15 listed)
- Spasticity greater than equal to 2 on the Modified Ashworth Scale in shoulder, elbow, wrist and finger joints of the more-affected upper extremity
- Scores > 3 on the Amount scale of Motor Activity Log indicating good use of the more-affected hand
- Has ataxia determined via finger-to-nose testing section of the Fugl Meyer Upper Extremity assessment
- Has proprioceptive sensory deficits determined via a score of 2 on the position sense section (section H) of the Fugl Meyer Upper Extremity assessment proprioception
- Excessive pain > equal to 4 on Visual Analog Scale in the more-affected upper extremity
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 random noise stimulation and functional electrical stimulation facilitated task practiceParticipants were randomized to one of the two intervention groups [transcranial current stimulation (tRNS) and functional electrical stimulation (FES) or FES with sham tRNS] before pre-intervention testing. After randomization, participants underwent pre-intervention testing, followed by intervention 3 times per week for 6 weeks. Each intervention session lasted for 1 hour, where tRNS or sham-tRNS were delivered concurrently with the FES-facilitated task practice. tRNS or sham-tRNS was delivered for the first 30 minutes. Both tRNS and sham tRNS were delivered by the Starstim system. FES was delivered using the Neuromove system. All participants were treated by a licensed occupational therapist, who was trained on a manualized protocol. | Device | sham tRNS and FES facilitated task practice, tRNS and FES facilitated task practice |
Primary outcome
Change From Baseline in Fugl Meyer Upper Extremity Scale at Post Treatment
Time frame: Baseline, 6 weeks.
Fugl Meyer Upper Extremity Scale (FMUE) is considered the gold standard in upper extremity rehabilitation trials and measures upper extremity motor control by asking the participant to perform various arm and hand motions. Items are scored on a 3-point ordinal scale with 0 representing inability to complete the item and 2 representing the ability to complete the item as asked. We will use the total score, which ranges from 0-66. Higher score suggest better upper extremity motor control. The FMUE has been shown to have good reliability and validity.
Change From Baseline in Fugl Meyer Upper Extremity Scale at 3 Months Post Treatment
Time frame: Baseline, 3 months.
Fugl Meyer Upper Extremity Scale (FMUE) is considered the gold standard in upper extremity rehabilitation trials and measures upper extremity motor control by asking the participant to perform various arm and hand motions. Items are scored on a 3-point ordinal scale with 0 representing inability to complete the item and 2 representing the ability to complete the item as asked. We will use the total score, which ranges from 0-66. Higher score suggest better upper extremity motor control. The FMUE has been shown to have good reliability and validity.
18 secondary outcomes
Change From Baseline in Wolf Motor Function Test at Post Treatment
Time frame: Baseline, 6 weeks.
Change From Baseline in Wolf Motor Function Test at 3 Months Post Treatment
Time frame: Baseline, 3 months.
Change From Baseline in Grip Strength at Post Treatment
Time frame: Baseline, 6 weeks.
Change From Baseline in Grip Strength at 3 Months Post Treatment
Time frame: Baseline, 3 months.
Change From Baseline in Hand Subscale of Stroke Impact Scale at Post Treatment
Time frame: Baseline, 6 weeks.
Change From Baseline in Hand Subscale of Stroke Impact Scale at 3 Months Post Treatment
Time frame: Baseline, 3 months.
Change From Baseline in Action Research Arm Test at Post Treatment
Time frame: Baseline, 6 weeks.
Change From Baseline in Action Research Arm Test at 3 Months Post Treatment
Time frame: Baseline, 3 months.
Change in Baseline in H-reflex at Post Treatment
Time frame: Baseline, 6 weeks.
Change in Baseline in H-reflex at 3 Months Post Treatment
Time frame: Baseline, 3 weeks.
Change in Baseline in Brain Activity at Post Treatment
Time frame: Baseline, 6 weeks.
Change in Baseline in Brain Activity at 3 Months Post Treatment
Time frame: Baseline, 3 months.
Change in Baseline in Muscle Activity at Post Treatment
Time frame: Baseline, 6 weeks.
Change in Baseline in Muscle Activity at 3 Months Post Treatment
Time frame: Baseline, 3 months.
Change in Baseline in Brain Excitability at Post Treatment
Time frame: Baseline, 6 weeks.
Change in Baseline in Brain Excitability at 3 Months Post Treatment
Time frame: Baseline, 3 months.
Change in in Baseline in Upper Extremity Kinematics at Post Treatment
Time frame: Baseline, 6 weeks.
Change in in Baseline in Upper Extremity Kinematics at 3 Months Post Treatment
Time frame: Baseline, 3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- 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, PhD principal investigator
University of Pittsburgh
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 random noise stimulation and functional electrical stimulation facilitated task practice in people with Stroke, 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 8 inclusion and 15 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 28 Dec 2022. 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?
Yes. Results are posted in the registry (first posted 28 Dec 2022). 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?
Change From Baseline in Fugl Meyer Upper Extremity Scale at Post Treatment (time frame: Baseline, 6 weeks.). 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 28 Dec 2022.