t-RNS After Hand Recovery in Chronic Stroke

Stroke Clinical Trial

Official title:

Combining Transcranial Random Noise Stimulation and Functional Electrical Stimulation to Enhance Hand Function in Individuals With Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05489146
• Other study ID #: PRO13090080
• Status: Completed
• Phase: N/A
• Start date: January 15, 2015
• Est. completion date: March 15, 2020

Study information

• Verified date: December 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Neuromotor Recovery and Rehabilitation Lab	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Amit Sethi	Neuroelectrics Corporation, Zynex Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 weeks.
Primary	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.	Baseline, 3 months.
Secondary	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.	Baseline, 6 weeks.
Secondary	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.	Baseline, 3 months.
Secondary	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.	Baseline, 6 weeks.
Secondary	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.	Baseline, 3 months.
Secondary	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.	Baseline, 6 weeks.
Secondary	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.	Baseline, 3 months.
Secondary	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.	Baseline, 6 weeks.
Secondary	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.	Baseline, 3 months.
Secondary	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.	Baseline, 6 weeks.
Secondary	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.	Baseline, 3 weeks.
Secondary	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.	Baseline, 6 weeks.
Secondary	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.	Baseline, 3 months.
Secondary	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.	Baseline, 6 weeks.
Secondary	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.	Baseline, 3 months.
Secondary	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.	Baseline, 6 weeks.
Secondary	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.	Baseline, 3 months.
Secondary	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.	Baseline, 6 weeks.
Secondary	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.	Baseline, 3 months.