Clinical trial NCT04195412: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke
Keywords: Stroke Rehabilitation
Transcranial Direct Current Stimulation
Neuroimaging
Neuronal Plasticity
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-12-11
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Treatment-related changes in functional magnetic resonance imaging
timeFrame: pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)
measure: Treatment-related changes in white matter
timeFrame: pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)
Secondary outcomes:
measure: Changes in Fugl-Meyer assessment of paretic upper limb motor function
timeFrame: 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)
measure: Changes in Jebsen-Taylor Hand Function Test scores
timeFrame: pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days
measure: Changes in Stroke Impact Scale scores
timeFrame: pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: D'Or Institute for Research and Education (IDOR)
Study officials:
affiliation: D'Or Institute for Research and Education (IDOR)
name: Fernanda F Tovar-Moll, PhD
role: STUDY_DIRECTOR
affiliation: D'Or Institute for Research and Education (IDOR)
name: Erika C Rodrigues, PhD
role: PRINCIPAL_INVESTIGATOR
References: