Repetitive Nerve Stimulation to Improve Recovery After Stroke

Stroke Clinical Trial

— RESTORES  

Official title:

Comparison Between Mechanisms Underlying Effects of Repetitive Peripheral Nerve Stimulation on Upper Limb Motor Performance in the Subacute and Chronic Phases After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03956407
• Other study ID #: 3019629
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: Hospital Israelita Albert Einstein
• Contact: Adriana Conforto
• Phone: +55-11-21519542
• Email: adrianabc[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral electrical stimulation (RPES) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. The objectives of this study are to compare the effects of RPES on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ischemic or hemorrhagic stroke confirmed by computed tomography or magnetic resonance imaging, between 7 days - 3 months before enrollment (subacute phase), and at least 6 months (chronic phase).

• Ability to perform at least 4 of 7 tasks performed in daily life that is part of the Jebsen-Taylor Test

Exclusion Criteria:

• Anesthesia of the paretic hand.

• Lesions affecting the motor cortex (hand area).

• Lesions affecting cerebellum, or cerebellar pathways in the brainstem.

• Severe spasticity at the paretic elbow, fist or fingers, defined with a score larger than 3 on the Modified Ashworth Scale.

• Neurological diseases such as Parkinson disease or chronic uncontrolled chronic disease such as cancer or cardiac insufficiency.

• Elbow pain or join deformity in the paretic limb.

• Pregnancy.

• Uncontrolled psychiatric disease.

• Aphasia or severe cognitive deficit.

• Inability to provide consent.

• Inability to attend the experimental sessions.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Repetitive peripheral nerve stimulation
Active repetitive peripheral nerve stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For active stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.
• Sham Repetitive peripheral nerve stimulation
Sham repetitive peripheral nerve stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For sham stimulation, intensities will be set at 10mv - 15mv lower than de lowest intensity able to induce sensory paraesthesias, and adjusted if required.

Locations

Country	Name	City	State
Brazil	Hospital São Rafael	Salvador	BA
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Jebsen-Taylor Test	Test of upper limb dexterity	Immediately after one session of intervention
Secondary	Change in lateral pinch strength	Pinch strength measured with dynamometer	Immediately after one session of intervention
Secondary	Change in gamma-aminobutyric acid levels in primary motor cortex	Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy	Immediately after one session of intervention
Secondary	Change in brain perfusion	Brain perfusion measured with magnetic resonance imaging - arterial spin labeling	Immediately after one session of intervention
Secondary	Change in grasp strength	Grasp strength measured with dynamometer	Immediately after one session of intervention