t-RNS After Hand Recovery in Chronic Stroke

NCT05489146 | Completed Results FDA Device

• 1 other identifier: PRO13090080
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; hand; brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (18)

• Change From Baseline in Wolf Motor Function Test at Post Treatment

  Baseline, 6 weeks.

• Change From Baseline in Wolf Motor Function Test at 3 Months Post Treatment

  Baseline, 3 months.

• Change From Baseline in Grip Strength at Post Treatment

  Baseline, 6 weeks.

• Change From Baseline in Grip Strength at 3 Months Post Treatment

  Baseline, 3 months.

• Change From Baseline in Hand Subscale of Stroke Impact Scale at Post Treatment

  Baseline, 6 weeks.

Study Arms (2)

tRNS and FES facilitated task practice

ACTIVE COMPARATOR

In this arm, participants received real transcranial random noise stimulation with FES facilitated task practice

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

Device: transcranial random noise stimulation and functional electrical stimulation facilitated task practice

Interventions

transcranial random noise stimulation and functional electrical stimulation facilitated task practice DEVICE

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; tRNS and FES facilitated task practice

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amit Sethi: lead
• Zynex Medical, Inc.: collaborator
• Neuroelectrics Corporation: collaborator

Study Sites (1)

Neuromotor Recovery and Rehabilitation Lab

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Amit Sethi, Associate Professor, Department of Occupational Therapy,
• Organization: University of Pittsburgh

asethi@pitt.edu

4123836619

Study Officials

• Amit Sethi, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, outcome assessor, investigator, and therapist providing the intervention were blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 5, 2022
• Study Start: January 15, 2015
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)