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

Stroke Clinical Trial

Official title:

Neuroplasticity Following Bihemispheric Transcranial Direct Current Stimulation and Motor Training in Chronic Stroke Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195412
• Other study ID #: PRJ1913
• Status: Recruiting
• Phase: Phase 2
• Start date: October 29, 2019
• Est. completion date: October 2021

Study information

• Verified date: December 2019
• Source: D'Or Institute for Research and Education
• Contact: Erika C Rodrigues, PhD
• Phone: +552138836000
• Email: erika.rodrigues[@]idor.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	D'Or Institute for Research and Education (IDOR)	Rio De Janeiro

Sponsors (4)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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).	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)
Secondary	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	pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days
Secondary	Changes in Stroke Impact Scale scores	Stroke Impact Scale scores changes from baseline to post-treatment and in subsequent follow-up	pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days