Clinical trial NCT03956407: Repetitive Nerve Stimulation to Improve Recovery After Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Neuromodulation
Peripheral stimulation
Motor function
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2019-05-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. Repetitive peripheral sensory stimulation (RPSS) 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 RPSS on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Jebsen-Taylor Test
timeFrame: Immediately after one session of intervention
Secondary outcomes:
measure: Change in lateral pinch strength
timeFrame: Immediately after one session of intervention
measure: Change in gamma-aminobutyric acid levels in primary motor cortex
timeFrame: Immediately after one session of intervention
measure: Change in brain perfusion
timeFrame: Immediately after one session of intervention
measure: Change in grasp strength
timeFrame: Immediately after one session of intervention
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital São Rafael
state: BA
Study officials:
References:
citation: Kroth JB, Handfas B, Rodrigues G, Zepeda F, Oliveira MA, Wang DJJ, de Azevedo Neto RM, Silva GS, Amaro E Jr, Sorinola IO, Conforto AB. Effects of Repetitive Peripheral Sensory Stimulation in the Subacute and Chronic Phases After Stroke: Study Protocol for a Pilot Randomized Trial. Front Neurol. 2022 Feb 16;13:779128. doi: 10.3389/fneur.2022.779128. eCollection 2022.