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Repetitive Nerve Stimulation to Improve Recovery After Stroke (RESTORES)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Repetitive peripheral nerve stimulation
Sham Repetitive peripheral nerve stimulation
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Neuromodulation, Peripheral stimulation, Motor function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital São RafaelRecruiting
  • Hospital Israelita Albert EinsteinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

Active, subacute stroke

Sham, subacute stroke

Active, chronic stroke

Sham, chronic stroke

Arm Description

Repetitive peripheral electrical stimulation (RPES) + Motor Training. Active RPES will be administered for 2 hours. After active session of RPES, the patient will receive motor training.

Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training

Repetitive peripheral electrical stimulation (RPES) + Motor Training. Active RPES will be administered for 2 hours. After active session of RPES, the patient will receive motor training.

Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training

Outcomes

Primary Outcome Measures

Change in Jebsen-Taylor Test
Test of upper limb dexterity

Secondary Outcome Measures

Change in lateral pinch strength
Pinch strength measured with dynamometer
Change in gamma-aminobutyric acid levels in primary motor cortex
Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy
Change in brain perfusion
Brain perfusion measured with magnetic resonance imaging - arterial spin labeling
Change in grasp strength
Grasp strength measured with dynamometer

Full Information

First Posted
May 16, 2019
Last Updated
October 27, 2022
Sponsor
Hospital Israelita Albert Einstein
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03956407
Brief Title
Repetitive Nerve Stimulation to Improve Recovery After Stroke
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Neuromodulation, Peripheral stimulation, Motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
An amendment for performance of a minimization procedure in order to enhance the probability of comparable characteristics between the groups was approved. The researcher responsible for minimization is not involved in data collection or analysis.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active, subacute stroke
Arm Type
Active Comparator
Arm Description
Repetitive peripheral electrical stimulation (RPES) + Motor Training. Active RPES will be administered for 2 hours. After active session of RPES, the patient will receive motor training.
Arm Title
Sham, subacute stroke
Arm Type
Sham Comparator
Arm Description
Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training
Arm Title
Active, chronic stroke
Arm Type
Active Comparator
Arm Description
Repetitive peripheral electrical stimulation (RPES) + Motor Training. Active RPES will be administered for 2 hours. After active session of RPES, the patient will receive motor training.
Arm Title
Sham, chronic stroke
Arm Type
Sham Comparator
Arm Description
Sham Comparator: Sham + Motor Training. Sham will be administered for 2 hours. After sham, the patient will receive motor training
Intervention Type
Device
Intervention Name(s)
Repetitive peripheral nerve stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Repetitive peripheral nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Jebsen-Taylor Test
Description
Test of upper limb dexterity
Time Frame
Immediately after one session of intervention
Secondary Outcome Measure Information:
Title
Change in lateral pinch strength
Description
Pinch strength measured with dynamometer
Time Frame
Immediately after one session of intervention
Title
Change in gamma-aminobutyric acid levels in primary motor cortex
Description
Gamma-aminobutyric acid levels measured with magnetic resonance imaging spectroscopy
Time Frame
Immediately after one session of intervention
Title
Change in brain perfusion
Description
Brain perfusion measured with magnetic resonance imaging - arterial spin labeling
Time Frame
Immediately after one session of intervention
Title
Change in grasp strength
Description
Grasp strength measured with dynamometer
Time Frame
Immediately after one session of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Conforto
Phone
+55-11-21519542
Email
adrianabc@einstein.br
First Name & Middle Initial & Last Name or Official Title & Degree
Larissa Servinsckins
Phone
+55-11-21513354
Email
larissa.servinsckins@einstein.br
Facility Information:
Facility Name
Hospital São Rafael
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzete N da Guarda, Prof
Phone
+55-71-3409-8000
Email
suzetefariasdaguarda@icloud.com
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
State/Province
SP
ZIP/Postal Code
05.652-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana B Conforto, Prof
Phone
+55-11-21519542
Email
adriana.conforto@einstein.br
First Name & Middle Initial & Last Name & Degree
Jesica B Kroth, PT
Phone
+55-11-21519542
Email
jessicakroth@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35250807
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.
Results Reference
derived

Learn more about this trial

Repetitive Nerve Stimulation to Improve Recovery After Stroke

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