t-RNS After Hand Recovery in Chronic Stroke

Amit Sethi

Status

Completed

Conditions

Stroke

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05489146

PRO13090080

Details and patient eligibility

About

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.

Full 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).

Enrollment

14 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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