Imaging the Effects of Bihemispheric Transcranial Stimulation and Motor Training After Stroke.
NCT ID: NCT04195412
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
24 participants
INTERVENTIONAL
2019-10-29
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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tDCS
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.
tDCS + upper limb rehabilitation
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.
Control
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.
Sham tDCS + upper limb rehabilitation
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.
Interventions
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tDCS + upper limb rehabilitation
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.
Sham tDCS + upper limb rehabilitation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
80 Years
ALL
No
Sponsors
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Rio de Janeiro State Research Supporting Foundation (FAPERJ)
OTHER_GOV
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
D'Or Institute for Research and Education
OTHER
Responsible Party
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Principal Investigators
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Fernanda F Tovar-Moll, PhD
Role: STUDY_DIRECTOR
D'Or Institute for Research and Education (IDOR)
Erika C Rodrigues, PhD
Role: PRINCIPAL_INVESTIGATOR
D'Or Institute for Research and Education (IDOR)
Locations
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D'Or Institute for Research and Education (IDOR)
Rio de Janeiro, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Erika C Rodrigues, PhD
Role: primary
Other Identifiers
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PRJ1913
Identifier Type: -
Identifier Source: org_study_id