- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03446378
tDCS on Motor Rehabiliation of Post Stroke Patients
tDCS Guided by Interhemispheric Assimetry Level on Upper Limb Rehabilitation of Post Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After given prior informed consent, volunteers will be classified and randomized using a website (randomization.com) by a non-involved researcher. At study beginning, volunteers will be evaluated through structured questionnaire. They will be submitted to the following evaluations: (i) Fugl-Meyer Scale; (ii) Motor Activity Log - 30; (iii) Functional independence measure; (iv) Patient Global Impression of Change Scale.
tDCS - 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 excitabilityquestionnaire will be applied.
Primary outcome measure Change in Fugl Meyer assesment of paretic upper limb motor function (time frame: baseline, before 6 session, after 10 sessions (10 days).
Fugl Meyer assesment 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, coordination and velocity. We will aplly only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points.
Secondary outcome measures Cortical excitabilit level it will be evaluated through single pulse transcranial magnetic stimulation paradigms (Neurosoft, Russia). Initially, rest motor threshold (RMT) will be determined by finding the lowest stimulator output that elicit motor evoked potential (MEP) around 50 μV (TMS Motor Threshold Assessment Tool -MTAT 2.0 - USA). For RMT measure, a figure-eight coil connected to the magnetic stimulator held manually at 45 degrees from the midline, will be placed over the right primary motor cortex of lesioned and non lesioned hemisphere (C3 and/or C4 - 10/20 System). After, motor evoked potential will be evaluet by 20 pulses firing with 120% of RMT.
Other pre specified outcome measures Change from Motor acitivy log - 30 (time frame: before and after 10 sessions (10 days)) MAL is a scripetd , structured, interview to measure real wordl upper extremity function. It was developed to measure the effects of therapy on the most impaired arm following stroke. Consists of 30 activities of daily living such as using a towel, brushing teath and picking up a glass. For a specificied time period post stroke, patients are asked about the extent of activity performance and how well it was performed by the most impaired arm. Response scale form o (never used) to 5 (same as pre stroke). Scores average for activity comprises the amount os use scale: the mean of scores of how well the acitivy was performed comprises the quality of movement. Ideaaly, ratings are obtained and as well as caregiver.
Functional independence measure is a questionanere used to evaluate the functional ability of the patient after the disease. The scale contains 18 items, divided in two subscales: motor and cogntion. The evaluated activites included eating dressins, bathing, transfer and others. Each item ranges from 7 (complete independe) to 1 (total dependence), higher scores indicate more independece.
EEG Patients will perform an assessment of brain activity through the EEG. Initially, patients will be placed seated in a chair at 90cm in front of a computer. Then, the equipment will be assembled, the points according to the 10-20 marking system will be identified: Cz, C3, C4, F3, F4, P3, P4, Fz and Pz.
The protocol will follow the sequence of six consecutive moments (1 minute each) to monitor the patient's brain activity through Neuro Spectrum software:
- 1st minute: REST: the patient will be relaxed, at rest, without any communication and with eyes open;
- 2nd minute: OBSERVE - the patient will observe the video of the movement hand to mouth;
- 3rd minute: EXECUTION - the patient will reproduce the movement of the video with healthy limb;
- 4th minute: IMAGINATION - the patient will imagine the previous movement;
- 5th minute: EXECUTION - the patient will reproduce the movement of the video with a paretic limb;
- 6th minute: IMAGINATION - the patient will imagine the previous movement; Changes on Patient Global Impression of Change Scale - (time frame: before 10 sessions, before 6 session, after 10 sessions (10 days))
The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better".
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50670-901
- Federal University of Pernambuco, Applied Neuroscience Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary or recurrent, ischemic or hemorrhagic stroke, confirmed by computed tomography or magnetic resonance imaging
- Chronic Stroke (> 3 months)
- Sensorimotor sequelae in an upper limb due to stroke
- Score ≥ 18 at Folstein Mini Mental State Examination
Exclusion Criteria:
• Prior neurological diseases
- Multiple brain lesions
- Metal implant in the skull and face
- Pacemaker
- History of seizures
- Epilepsy
- Pregnancy
- Hemodynamic instability
- Traumatic orthopedic injuries of upper limb that compromise the function
- Altered medication for less than 3 months or who underwent botulinum toxin for less than 6 months
- Performing physical therapy elsewhere during the period of intervention
- Patients who do not present RMT in the healthy hemisphere.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anodal tDCS + physical therapy
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 contralateral supraorbital region.
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
|
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 questionnaire will be applied
all patients will be submitted to a protocol of exercise with differents levels according with motor learing and neuroplasticity principles.
All physical therapists were trained before the study.
|
Experimental: Cathodal tDCS + physical therapy
tDCS will be applied with duration of 20 minutes, intensity of 2 mA where cathodal electrode will be on the affected hemisphere and the anodal electrode, on the contralateral supraorbital region.
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
|
all patients will be submitted to a protocol of exercise with differents levels according with motor learing and neuroplasticity principles.
All physical therapists were trained before the study.
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 questionnaire will be applied
|
Sham Comparator: Sham tDCS + physical therapy
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 contralateral supraorbital region.
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 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
|
all patients will be submitted to a protocol of exercise with differents levels according with motor learing and neuroplasticity principles.
All physical therapists were trained before the study.
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 questionnaire will be applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fugl Meyer assesment of paretic upper limb motor function
Time Frame: before 10 sessions, before 6 session and after 10 sessions - each session means 1 day
|
Fugl Meyer assesment 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, coordination and velocity.
We will aplly only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points.
Higher scores indicates better outcomes
|
before 10 sessions, before 6 session and after 10 sessions - each session means 1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortical excitability level
Time Frame: before and after 10 sessions - each session means 1 day
|
it will be evaluated through single pulse transcranial magnetic stimulation paradigms (Neurosoft, Russia).
Initially, rest motor threshold (RMT) will be determined by finding the lowest stimulator output that elicit motor evoked potential (MEP) around 50 μV (TMS Motor Threshold Assessment Tool -MTAT 2.0 - USA).
For RMT measure, a figure-eight coil connected to the magnetic stimulator held manually at 45 degrees from the midline, will be placed over the right primary motor cortex of lesioned and non lesioned hemisphere (C3 and/or C4 - 10/20 System).
After, motor evoked potential will be evaluet by 20 pulses firing with 120% of RMT.
Higher values of RMT indicates low cortical excitabilit level.
|
before and after 10 sessions - each session means 1 day
|
Change from Motor acitivy log - 30
Time Frame: before and after 10 sessions - each session means 1 day
|
MAL is a scripetd , structured, interview to measure real wordl upper extremity function.
It was developed to measure the effects of therapy on the most impaired arm following stroke.
Consists of 30 activities of daily living such as using a towel, brushing teath and picking up a glass.
For a specificied time period post stroke, patients are asked about the extent of activity performance and how well it was performed by the most impaired arm.
Response scale form o (never used) to 5 (same as pre stroke).
Scores average for activity comprises the amount os use scale: the mean of scores of how well the acitivy was performed comprises the quality of movement.
Ideaaly, ratings are obtained and as well as caregiver.
Higher scores indicates better outcomes
|
before and after 10 sessions - each session means 1 day
|
Change from Functional independence measure
Time Frame: before and after 10 sessions - each session means 1 day
|
Functional independence measure is a questionanere used to evaluate the functional ability of the patient after the disease.
The scale contains 18 items, divided in two subscales: motor and cogntion.
The evaluated activites included eating dressins, bathing, transfer and others.
Each item ranges from 7 (complete independe) to 1 (total dependence), higher scores indicate more independece.
Higher scores indicates better outcomes
|
before and after 10 sessions - each session means 1 day
|
Electroencephalography
Time Frame: before and after 10 sessions - each session means 1 day
|
Patients will perform an assessment of brain activity through the EEG.
Initially, patients will be placed seated in a chair at 90cm in front of a computer.
Then, the equipment will be assembled, the points according to the 10-20 marking system will be identified: Cz, C3, C4, F3, F4, P3, P4, Fz and Pz.
|
before and after 10 sessions - each session means 1 day
|
Changes on Patient Global Impression of Change Scale
Time Frame: before the 6 session and after 10 sessions - each session means 1 day
|
The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better".Higher scores indicates better outcomes
|
before the 6 session and after 10 sessions - each session means 1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tDCS_stroke
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on Anodal tDCS
-
Riphah International UniversityCompleted
-
University of WaterlooThe Hong Kong Polytechnic UniversityRecruitingMacular DegenerationHong Kong, Canada
-
University of WaterlooThe Hong Kong Polytechnic UniversityCompleted
-
University of MiamiActive, not recruiting
-
Hospital Ernesto DornellesUnknown
-
University of LiegeCompletedDisorders of Consciousness | Minimally Conscious State | Vegetative StateBelgium
-
University of TromsoHelse NordCompleted
-
University of LiegeCompletedDisorder of Consciousness | Minimally Conscious State | Vegetative StateBelgium
-
University of LiegeCompletedDisorders of Consciousness | Minimally Conscious State | Vegetative StateBelgium
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedMotor Activity | Motor NeuroplasticityUnited States