t-RNS After Hand Recovery in Chronic Stroke

Completed · Not applicable · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT05489146

Run by

Amit Sethi

People needed

14

Starts

2015-01-15

Expected to finish

2020-03-15

Last updated by the study team

2022-12-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Neuromotor Recovery and Rehabilitation Lab — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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