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Imaging the Effects of Bihemispheric Transcranial Stimulation and Motor Training After Stroke.

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
tDCS + upper limb rehabilitation
Sham tDCS + upper limb rehabilitation
Sponsored by
D'Or Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke Rehabilitation, Transcranial Direct Current Stimulation, Neuroimaging, Neuronal Plasticity

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic Stroke (> 12 months)
  • Upper limb sensorimotor sequelae due to stroke affecting only one cerebral hemisphere
  • The structural integrity of the corpus callosum sensorimotor
  • Showing ability to perform some movement with the paretic upper limb: at least minimal active mobility of the wrist and two fingers of the paretic hand.
  • Score ≥ 18 at Folstein Mini-Mental State Examination

Exclusion Criteria:

  • Score ≥ 4 at Ashworth Scale
  • MRI or tDCS contraindications (cardiac pacemakers; implanted medication pumps; cochlear, or eye implants; craniotomy, skin lesions at the site of stimulation; surgical clips in or near the brain; claustrophobia, history of seizures, permanent makeup or tattoos with metallic dyes…)
  • Prior neurological diseases
  • Hemodynamic instability
  • Pregnancy
  • Traumatic or orthopedic lesion limiting the range of upper limb motion
  • Severe comprehension deficits, apraxia or neglect that would interfere with performing the study tasks
  • Score > 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke

Sites / Locations

  • D'Or Institute for Research and Education (IDOR)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS

Control

Arm Description

Bihemispheric tDCS will be applied. The anode will be placed on the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. After stimulation, individual and intensive upper limb rehabilitation will be performed.

Bihemispheric sham tDCS will be applied. The anode will be placed on the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. After sham stimulation, individual and intensive upper limb rehabilitation will be performed.

Outcomes

Primary Outcome Measures

Treatment-related changes in functional magnetic resonance imaging
Brain functional changes from baseline to post-treatment
Treatment-related changes in white matter
Brain structural (white matter) changes from baseline to post-treatment

Secondary Outcome Measures

Changes in Fugl-Meyer assessment of paretic upper limb motor function
Fugl-Meyer Upper Extremity (FM-UE) Scale of Motor Impairment scores changes from baseline to post-treatment, 30 and 90 days later (follow up).
Changes in Jebsen-Taylor Hand Function Test scores
Fugl-Meyer Upper Extremity (FM-UE) Scale of Motor Impairment scores changes from baseline to post-treatment and in subsequent follow-up
Changes in Stroke Impact Scale scores
Stroke Impact Scale scores changes from baseline to post-treatment and in subsequent follow-up

Full Information

First Posted
October 29, 2019
Last Updated
December 9, 2019
Sponsor
D'Or Institute for Research and Education
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT04195412
Brief Title
Imaging the Effects of Bihemispheric Transcranial Stimulation and Motor Training After Stroke.
Official Title
Neuroplasticity Following Bihemispheric Transcranial Direct Current Stimulation and Motor Training in Chronic Stroke Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
D'Or Institute for Research and Education
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

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

5. Study Description

Brief Summary
Functional and structural magnetic resonance imaging (MRI) will be used to investigate neural correlates of bihemispheric transcranial direct current stimulation (tDCS) associated with upper limb rehabilitation in chronic stroke patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individualized rehabilitation. Neuroimage will be employed before and after the intervention to investigate neural correlates of expected changes in motor function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke Rehabilitation, Transcranial Direct Current Stimulation, Neuroimaging, Neuronal Plasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS
Arm Type
Experimental
Arm Description
Bihemispheric tDCS will be applied. The anode will be placed on the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. After stimulation, individual and intensive upper limb rehabilitation will be performed.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Bihemispheric sham tDCS will be applied. The anode will be placed on the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. After sham stimulation, individual and intensive upper limb rehabilitation will be performed.
Intervention Type
Device
Intervention Name(s)
tDCS + upper limb rehabilitation
Intervention Description
Stimulation will be applied for 20 minutes by a DC stimulator (NeuroConn, Germany). During each stimulation section, a pair of saline-soaked sponge electrodes (surface 24 cm²) will be placed over C3 and C4, according to the International 10-20 EEG system. Stimulation intensity will be 2 mA with current ramping up and down of 10 seconds each. The stimulation will be followed by 40 minutes of upper limb rehabilitation. Experimental sessions will be repeated five times per week to complete 10 sessions.
Intervention Type
Device
Intervention Name(s)
Sham tDCS + upper limb rehabilitation
Intervention Description
Sham stimulation will be applied for 20 minutes by a DC stimulator (NeuroConn, Germany). During each sham stimulation section, a pair of saline-soaked sponge electrodes (surface 24 cm²) will be placed over C3 and C4, according to the International 10-20 EEG system. The anode will be placed to the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. Sham tDCS will be performed by ramping current flow for the first 10 seconds of stimulation, but switching the stimulator off automatically after 30 seconds. The sham stimulation will be followed by 40 minutes of upper limb rehabilitation. Experimental sessions will be repeated five times per week to complete 10 sessions.
Primary Outcome Measure Information:
Title
Treatment-related changes in functional magnetic resonance imaging
Description
Brain functional changes from baseline to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)
Title
Treatment-related changes in white matter
Description
Brain structural (white matter) changes from baseline to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)
Secondary Outcome Measure Information:
Title
Changes in Fugl-Meyer assessment of paretic upper limb motor function
Description
Fugl-Meyer Upper Extremity (FM-UE) Scale of Motor Impairment scores changes from baseline to post-treatment, 30 and 90 days later (follow up).
Time Frame
pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment); 30 days follow up (30 days after completing treatment) and 90 days follow up (90 days after completing treatment)
Title
Changes in Jebsen-Taylor Hand Function Test scores
Description
Fugl-Meyer Upper Extremity (FM-UE) Scale of Motor Impairment scores changes from baseline to post-treatment and in subsequent follow-up
Time Frame
pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days
Title
Changes in Stroke Impact Scale scores
Description
Stroke Impact Scale scores changes from baseline to post-treatment and in subsequent follow-up
Time Frame
pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Stroke (> 12 months) Upper limb sensorimotor sequelae due to stroke affecting only one cerebral hemisphere The structural integrity of the corpus callosum sensorimotor Showing ability to perform some movement with the paretic upper limb: at least minimal active mobility of the wrist and two fingers of the paretic hand. Score ≥ 18 at Folstein Mini-Mental State Examination Exclusion Criteria: Score ≥ 4 at Ashworth Scale MRI or tDCS contraindications (cardiac pacemakers; implanted medication pumps; cochlear, or eye implants; craniotomy, skin lesions at the site of stimulation; surgical clips in or near the brain; claustrophobia, history of seizures, permanent makeup or tattoos with metallic dyes…) Prior neurological diseases Hemodynamic instability Pregnancy Traumatic or orthopedic lesion limiting the range of upper limb motion Severe comprehension deficits, apraxia or neglect that would interfere with performing the study tasks Score > 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erika C Rodrigues, PhD
Phone
+552138836000
Email
erika.rodrigues@idor.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda F Tovar-Moll, PhD
Organizational Affiliation
D'Or Institute for Research and Education (IDOR)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erika C Rodrigues, PhD
Organizational Affiliation
D'Or Institute for Research and Education (IDOR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
D'Or Institute for Research and Education (IDOR)
City
Rio De Janeiro
ZIP/Postal Code
22281100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika C Rodrigues, PhD
Phone
552138836000
Email
erika.rodrigues@idor.org

12. IPD Sharing Statement

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Imaging the Effects of Bihemispheric Transcranial Stimulation and Motor Training After Stroke.

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