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

NCT04195412 | Unknown Phase 2

• 1 other identifier: PRJ1913
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke Rehabilitation; Transcranial Direct Current Stimulation; Neuroimaging; Neuronal Plasticity

Outcome Measures

Primary Outcomes (2)

• Treatment-related changes in functional magnetic resonance imaging

  Brain functional changes from baseline to post-treatment

  pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)

• Treatment-related changes in white matter

  Brain structural (white matter) changes from baseline to post-treatment

  pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)

Secondary Outcomes (3)

• Changes in Fugl-Meyer assessment of paretic upper limb motor function

  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)

• Changes in Jebsen-Taylor Hand Function Test scores

  pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days

• Changes in Stroke Impact Scale scores

  pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days

Study Arms (2)

tDCS

EXPERIMENTAL

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.

Device: tDCS + upper limb rehabilitation

Control

SHAM COMPARATOR

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.

Device: Sham tDCS + upper limb rehabilitation

Interventions

tDCS + upper limb rehabilitation DEVICE

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.

tDCS

Sham tDCS + upper limb rehabilitation DEVICE

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.

Control

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

D'Or Institute for Research and Education (IDOR)

Rio de Janeiro, 22281100, Brazil

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Fernanda F Tovar-Moll, PhD

  D'Or Institute for Research and Education (IDOR)

  STUDY DIRECTOR

• Erika C Rodrigues, PhD

  D'Or Institute for Research and Education (IDOR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika C Rodrigues, PhD

CONTACT

+552138836000; erika.rodrigues@idor.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: December 11, 2019
• Study Start: October 29, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: December 11, 2019

Record last verified: 2019-12

Locations

BR (1)