Clinical trial NCT05489146: t-RNS After Hand Recovery in Chronic Stroke
Official title: Combining Transcranial Random Noise Stimulation and Functional Electrical Stimulation to Enhance Hand Function in Individuals With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
hand
brain stimulation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Zynex Medical, Inc.
name: Neuroelectrics Corporation
First posted: 2022-08-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Fugl Meyer Upper Extremity Scale at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change From Baseline in Fugl Meyer Upper Extremity Scale at 3 Months Post Treatment
timeFrame: Baseline, 3 months.
Secondary outcomes:
measure: Change From Baseline in Wolf Motor Function Test at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change From Baseline in Wolf Motor Function Test at 3 Months Post Treatment
timeFrame: Baseline, 3 months.
measure: Change From Baseline in Grip Strength at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change From Baseline in Grip Strength at 3 Months Post Treatment
timeFrame: Baseline, 3 months.
measure: Change From Baseline in Hand Subscale of Stroke Impact Scale at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change From Baseline in Hand Subscale of Stroke Impact Scale at 3 Months Post Treatment
timeFrame: Baseline, 3 months.
measure: Change From Baseline in Action Research Arm Test at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change From Baseline in Action Research Arm Test at 3 Months Post Treatment
timeFrame: Baseline, 3 months.
measure: Change in Baseline in H-reflex at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change in Baseline in H-reflex at 3 Months Post Treatment
timeFrame: Baseline, 3 weeks.
measure: Change in Baseline in Brain Activity at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change in Baseline in Brain Activity at 3 Months Post Treatment
timeFrame: Baseline, 3 months.
measure: Change in Baseline in Muscle Activity at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change in Baseline in Muscle Activity at 3 Months Post Treatment
timeFrame: Baseline, 3 months.
measure: Change in Baseline in Brain Excitability at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change in Baseline in Brain Excitability at 3 Months Post Treatment
timeFrame: Baseline, 3 months.
measure: Change in in Baseline in Upper Extremity Kinematics at Post Treatment
timeFrame: Baseline, 6 weeks.
measure: Change in in Baseline in Upper Extremity Kinematics at 3 Months Post Treatment
timeFrame: Baseline, 3 months.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Neuromotor Recovery and Rehabilitation Lab
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Amit Sethi, PhD
role: PRINCIPAL_INVESTIGATOR
References: