Trial Outcomes & Findings for t-RNS After Hand Recovery in Chronic Stroke (NCT NCT05489146)
NCT ID: NCT05489146
Last Updated: 2022-12-28
Results Overview
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.
COMPLETED
NA
14 participants
Baseline, 6 weeks.
2022-12-28
Participant Flow
Participant milestones
| Measure |
tRNS and FES Facilitated Task Practice
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
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|---|---|---|
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Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
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0
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
t-RNS After Hand Recovery in Chronic Stroke
Baseline characteristics by cohort
| Measure |
tRNS and FES Facilitated Task Practice
n=8 Participants
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
n=6 Participants
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
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Total
n=14 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
65.62 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
54 years
STANDARD_DEVIATION 13.64 • n=7 Participants
|
62.85 years
STANDARD_DEVIATION 8.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Fugl Meyer Upper Extremity Scale
|
28.5 score on a scale
STANDARD_DEVIATION 9.46 • n=5 Participants
|
30.33 score on a scale
STANDARD_DEVIATION 12.27 • n=7 Participants
|
29.28 score on a scale
STANDARD_DEVIATION 10.34 • n=5 Participants
|
|
Baseline Wolf Motor Function Test
|
41.88 Seconds
STANDARD_DEVIATION 33.07 • n=5 Participants
|
49.32 Seconds
STANDARD_DEVIATION 29.43 • n=7 Participants
|
45.07 Seconds
STANDARD_DEVIATION 30.60 • n=5 Participants
|
|
Baseline Grip Strength
|
12.90 Pounds
STANDARD_DEVIATION 7.46 • n=5 Participants
|
13.15 Pounds
STANDARD_DEVIATION 6.89 • n=7 Participants
|
13.01 Pounds
STANDARD_DEVIATION 6.94 • n=5 Participants
|
|
Baseline of Hand Subscale of Stroke Impact Scale
|
9.75 score on a scale
STANDARD_DEVIATION 3.92 • n=5 Participants
|
11.17 score on a scale
STANDARD_DEVIATION 2.64 • n=7 Participants
|
10.35 score on a scale
STANDARD_DEVIATION 3.38 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
tRNS and FES Facilitated Task Practice
n=8 Participants
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
n=6 Participants
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
|---|---|---|
|
Change From Baseline in Fugl Meyer Upper Extremity Scale at Post Treatment
|
35.25 score on a scale
Standard Error 4.27
|
33.5 score on a scale
Standard Error 3.83
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
tRNS and FES Facilitated Task Practice
n=8 Participants
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
n=6 Participants
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
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|---|---|---|
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Change From Baseline in Fugl Meyer Upper Extremity Scale at 3 Months Post Treatment
|
37.25 score on a scale
Standard Error 4.73
|
33.5 score on a scale
Standard Error 4.68
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks.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.
Outcome measures
| Measure |
tRNS and FES Facilitated Task Practice
n=8 Participants
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
n=6 Participants
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
|---|---|---|
|
Change From Baseline in Wolf Motor Function Test at Post Treatment
|
33.46 Seconds
Standard Error 9.24
|
42.79 Seconds
Standard Error 13.58
|
SECONDARY outcome
Timeframe: Baseline, 3 months.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.
Outcome measures
| Measure |
tRNS and FES Facilitated Task Practice
n=8 Participants
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
n=6 Participants
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
|---|---|---|
|
Change From Baseline in Wolf Motor Function Test at 3 Months Post Treatment
|
34.18 Seconds
Standard Error 10.52
|
37.38 Seconds
Standard Error 12.13
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks.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.
Outcome measures
| Measure |
tRNS and FES Facilitated Task Practice
n=8 Participants
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
n=6 Participants
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
|---|---|---|
|
Change From Baseline in Grip Strength at Post Treatment
|
17.50 Pounds
Standard Error 5.53
|
15.60 Pounds
Standard Error 3.21
|
SECONDARY outcome
Timeframe: Baseline, 3 months.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.
Outcome measures
| Measure |
tRNS and FES Facilitated Task Practice
n=8 Participants
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
n=6 Participants
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
|---|---|---|
|
Change From Baseline in Grip Strength at 3 Months Post Treatment
|
16.49 Pounds
Standard Error 3.98
|
16.19 Pounds
Standard Error 4.11
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks.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.
Outcome measures
| Measure |
tRNS and FES Facilitated Task Practice
n=8 Participants
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
n=6 Participants
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
|---|---|---|
|
Change From Baseline in Hand Subscale of Stroke Impact Scale at Post Treatment
|
15.88 score on a scale
Standard Error 1.47
|
12.17 score on a scale
Standard Error 1.92
|
SECONDARY outcome
Timeframe: Baseline, 3 months.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.
Outcome measures
| Measure |
tRNS and FES Facilitated Task Practice
n=8 Participants
In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
Sham tRNS and FES Facilitated Task Practice
n=6 Participants
In this arm, participants received sham transcranial random noise stimulation with FES facilitated task practice
transcranial random noise stimulation and functional electrical stimulation facilitated task practice: 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.
|
|---|---|---|
|
Change From Baseline in Hand Subscale of Stroke Impact Scale at 3 Months Post Treatment
|
14.38 score on a scale
Standard Error 1.63
|
12.67 score on a scale
Standard Error 1.94
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 weeks.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 weeks.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 weeks.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 weeks.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 weeks.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 weeks.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months.Population: Data was not collected because of the feasibility of testing or participants' burden.
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.
Outcome measures
Outcome data not reported
Adverse Events
tRNS and FES Facilitated Task Practice
Sham tRNS and FES Facilitated Task Practice
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amit Sethi, Associate Professor, Department of Occupational Therapy,
University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place