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

Phase 2

• Conditions: Stroke
• Interventions: Device: Sham tDCS + upper limb rehabilitation; Device: tDCS + upper limb rehabilitation

• Registration Number: NCT04195412
• Lead Sponsor: D'Or Institute for Research and Education

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-29
• Study First Submitted: 2019-10-29
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-09
• Last Update Submitted: 2019-12-09
• Study First Posted: 2019-12-11
• Last Update Posted: 2019-12-11
• Primary Completion: 2020-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sham tDCS + upper limb rehabilitation	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.
tDCS	tDCS + upper limb rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Treatment-related changes in functional magnetic resonance imaging	pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)	Brain functional changes from baseline to post-treatment
Treatment-related changes in white matter	pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)	Brain structural (white matter) changes from baseline to post-treatment

Secondary Outcome Measures

Name	Time	Method
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	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	pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days	Stroke Impact Scale scores changes from baseline to post-treatment and in subsequent follow-up
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)	Fugl-Meyer Upper Extremity (FM-UE) Scale of Motor Impairment scores changes from baseline to post-treatment, 30 and 90 days later (follow up).

Trial Locations

Locations (1)

D'Or Institute for Research and Education (IDOR); 🇧🇷 Rio De Janeiro, Brazil