tDCS in Poststroke on Upper Limb Rehabilitation
Transcranial Direct Current Stimulation in Rehabilitation of Chronic Stroke Patients: Multicenter Clinical Trial
1 other identifier
interventional
24
1 country
3
Brief Summary
In this study, the investigators wondered whether bihemispheric transcranial direct current stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper limb rehabilitation of chronic stroke patients. Moreover, the study aims to investigate the pattern of physiological variables involved in the recovery of these patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individual physical therapy session.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 stroke
Started Dec 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 14, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 18, 2014
May 1, 2014
1 year
June 14, 2014
June 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Fugl-Meyer assessment of paretic upper limb motor function
Fugl-Meyer assessment is used to measure motor control recovery. It is a 226-point scoring system that includes the following sessions: range of motion, pain, sensation, motor function of upper and lower limbs, balance and coordination/velocity. We will apply only two sessions: upper limb motor function and coordination/velocity. These sessions totalize 66 points.The instrument provides a reliable and valid measure of specific motor function that is also sensitive to change.
baseline, after sessions, 30 and 90 days
Secondary Outcomes (1)
Change from Motor Activity Log-30
baseline, after sessions, 30 and 90 days
Other Outcomes (1)
Change from Jebsen-Taylor Hand Function Test
baseline, after sessions, 30 and 90 days
Study Arms (2)
tDCS + physical therapy
EXPERIMENTALFirstly, patients will undergo electrophysiological evaluation: motor evoked potential, motor threshold and silent period in both hemispheres. After those procedures, bihemispheric tDCS will be applied with duration of 20 minutes, intensity of 2 mA where anodal electrode will be on the affected hemisphere and the cathodal electrode, on the non-affected hemisphere. After tDCS, patients will be submitted to 40 minutes of physical therapy protocol. Experimental sessions will be repeated five times per week to complete 10 sessions.
Sham tDCS + physical therapy
SHAM COMPARATORFirstly, patients will undergo electrophysiological evaluation: motor evoked potential, motor threshold and silent period in both hemispheres. After those procedures, bihemispheric sham tDCS will be applied. Anodal electrode will be on the affected hemisphere and the cathodal electrode, on the non-affected hemisphere. Sham tDCS will be performed by ramping current flow for the first 10 seconds of stimulation, but switching the stimulator off after 30 seconds. After bihemispheric sham tDCS, patients will be submitted to 40 minutes of physical therapy protocol. Experimental sessions will be repeated five times per week to complete 10 sessions.
Interventions
Bihemispheric tDCS involves application of very low-amplitude direct currents (2 mA or less) via surface scalp electrodes. It produces a sub-sensory level of electrical stimulation wich remains imperceptible by most people during application. In a small percentage of patients, it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. Depending on the polarity, tDCS can increase or decrease corticomotor excitability. Anodal tDCS is able to facilitate neurons depolarization - increasing cortical excitability - while, on the other hand, cathodal tDCS hyperpolarizes the resting membrane potential, reducing the neuronal firing and the cortical excitability. Other: Physical Therapy
Eligibility Criteria
You may qualify if:
- Primary or recurrent, ischemic or hemorrhagic stroke, confirmed by computed tomography or magnetic resonance imaging
- Chronic Stroke (\> 12 months)
- Sensorimotor sequelae in an upper limb due to stroke
- Score ≥ 18 at Folstein Mini Mental State Examination
- Score ≥ 4 at Ashworth Scale
- Minimal active wrist movement (flexion and extension)
- At least one pinch movement
You may not qualify if:
- Prior neurological diseases
- Multiple brain lesions
- Metal implant in the skull and face
- Pacemaker
- History of seizures
- Epilepsy
- Pregnancy
- Hemodynamic instability
- Performing physical therapy elsewhere during the period of intervention
- Score \> 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke
- Traumatic or orthopedic lesion limiting the range of motion of upper limb
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-900, Brazil
D'Or Institute for Research and Education (ID'Or)
Rio de Janeiro, Rio de Janeiro, Brazil
University Center Augusto Mota (UNISUAM)
Rio de Janeiro, Rio de Janeiro, Brazil
Related Publications (1)
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kátia Monte-Silva, PhD
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
June 14, 2014
First Posted
June 18, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
June 18, 2014
Record last verified: 2014-05