StrokePhase 2NCT02166619
tDCS in Poststroke on Upper Limb Rehabilitation
A Phase 2 study testing tDCS + physical therapy in people with Stroke, run by Universidade Federal de Pernambuco at 3 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS + physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesBrazil
- Study dates
- Dec 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior neurological diseases
- Multiple brain lesions
- Metal implant in the skull and face
- Pacemaker
- History of seizures
- Epilepsy
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 3 recruiting
- Recruiting
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-900
Adriana Baltar, PT, +55 81 91296401, adrianabaltarmaciel@gmail.com
Maíra Souza, PT, +55 81 89496886, mairasouza77@gmail.com
- Recruiting
D'Or Institute for Research and Education (ID'Or)
Rio de Janeiro, Rio de Janeiro
Fernanda Moll, PhD, fernandanrn@hotmail.com
Fernanda Moll, PhD
- Recruiting
University Center Augusto Mota (UNISUAM)
Rio de Janeiro, Rio de Janeiro
Érika Rodrigues, PhD, +55 21 9971244796, erikacrodrigues@gmail.com
Laura Oliveira, PhD, +55 21 934844107, lauraoliveira.ft@gmail.com
About this study
Official title: Transcranial Direct Current Stimulation in Rehabilitation of Chronic Stroke Patients: Multicenter Clinical Trial
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.
Read the detailed description
Patients will undergo behavioral and electrophysiological evaluation before, immediately after, 30 and 90 days after 10 sessions (follow ups). They will be submitted to the following evaluations: (i) Fugl-Meyer Scale; (ii) Jebsen-Taylor hand functional test; (iii) Box-Block test; (iv) Motor Activity Log - 30; (v) Geriatric Depression Scale - 15; (vi) Beck Depression Inventory; (vii) Stroke Impact Scale; (viii) Hand Grip Strength and (iv) Modified Ashworth Scale. In addition, one question of motivation will be answered by patients in different stages of the treatment: (i) motivation regarding their own life at the beginning and ending of the treatment; (ii) daily motivation at the beginning of each session; (iii) motivation of the last week at the fifth and tenth sessions; (iv) motivation regarding their own life at 30 and 90 days after the ending of the treatment. A visual scale will be used to assess patient's motivation through five potential answers: "very little", "little", "more or less", "very much" and "extremely".
Electrophysiological measures will be performed before and after each session and in follow ups.
Evaluation of brain activity will be performed using single-pulse transcranial magnetic stimulation (TMS-p) only in Recife Centre. Magnetic stimulation (Neurosoft, Russia) will be applied through a figure-8 coil to determine motor cortex representation of first dorsal interosseus muscle (hotspot) and performed the following electrophysiological measures, in both cerebral hemispheres, to assess cortical activity: (i) Motor Evoked Potential (MEP); (ii) Active motor threshold (AMT) and (iii) Silent period (PS).
Evaluation of brain activity will be performed using single-pulse transcranial magnetic stimulation (TMS-p) only in Recife Centre. Magnetic stimulation (Neurosoft, Russia) will be applied through a figure-8 coil kept at a 45 degree angle relative to the sagittal line and pointed to the anterior region of the skull. Firstly, patients will be instructed to sit in a chair and to search a comfortable position. TMS-p will be applied in both motor cortex, healthy and injured, to determine the cortical representation of first dorsal interosseus muscle. The hotspot will be considered the most excitable area, with more intense motor evoked potential (MEP), measured by electromyography.
The following electrophysiological measures will be performed in both cerebral hemispheres to assess cortical activity:
(i) Motor Evoked Potential (MEP) : the intensity of magnetic stimulator is adjusted to produce an average MEP of 1.0 mV. TMS-p will be applied in the area of cortical representation of the first dorsal interosseous and mean responses to stimuli should reach 0.8 mV to 1.2 mV.
(ii) Active motor threshold (AMT) : will be request to the patient to perform contraction of the first interosseous muscle and then, will be given ten pulses by TMS-p to determinate active motor threshold. Motor threshold corresponds to the lowest intensity of TMS-p to produce a MEP of 50 μV in 50% of the pulses applied to the hotspot.
(iii) Silent period (PS) : is the interval of time that usually is observed absence of electromyographic activity. Occurs immediately after the registration of MEP during voluntary contraction of the target muscle (PEMvc - motor evoked potentials recorded during voluntary contraction). Higher the intensity of the magnetic stimulation, longer the duration of PS.
During tDCS application, patients will be seated in a comfortable chair with head and arms rests. Current will be applied by a DC stimulator (NeuroConn, Germany) using a pair of saline-soaked sponge electrodes (surface 24 cm²).
Bihemispheric tDCS will be applied to primary motor cortex (M1) in left and right hemispheres. These points correspond to C3 and C4 according to International 10-20 EEG system. Anode will be placed to M1 in affected hemisphere, while the cathode is positioned to M1 over the unaffected hemisphere. Parameters of current intensity and duration (dose) used were previously established in poststroke patients: 2 mA stimulation intensity for 20 minutes with current ramping up and down of 10 seconds each.
Sham tDCS has been used in several studies to evaluate the effect of active tDCS. In placebo stimulation, intensity and electrode's positions are the same as in the active group, however, current duration is only 30 seconds, with current ramping up and down of 10 seconds each. Moreover, the electrostimulation device is automatically turned off without patient's perception. Thus, patients experience early sensations (mild to moderate tingling) in stimulation site without inducing effect. Moreover, after each tDCS session, patients will answer adverse effects questionnaire.
After apply tDCS, 40 minutes of individual and intensive physical therapy session will be performed. Goals of the physical therapy protocol were discussed based in neuroplasticity principles by a group of experienced physiotherapists. Physical therapy activities will be focused on rehabilitation of upper limb and will cover the following purposes: flexibility, transfer and posture, coordination, balance and sensorial stimulation. Depending on patient's ability, a program of activities for each purpose will be adapted by a trained physical therapist.
The study will be conducted simultaneously in three research centers in Brazil: Applied Neuroscience Laboratory (LANA), Universidade Federal de Pernambuco (UFPE), Pernambuco, Brazil; D'Or Institute for Research and Education (ID'Or), Botafogo, Rio de Janeiro, Brazil and at the University Center Augusto Mota (UNISUAM), Bonsucesso Unit, Rio de Janeiro, Brazil.
- Conditions
- Stroke
- Being tested
- tDCS + physical therapy
- Keywords
- Stroke, Rehabilitation, Electric stimulation therapy, Neuroplasticity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS + physical therapyDevice
Also called non invasive brain stimulation, neuroConn (Germany)
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
| Study group | Role | What they receive |
|---|---|---|
| tDCS + physical therapy | Experimental | Firstly, 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. Receives: Device: tDCS + physical therapy |
| Sham tDCS + physical therapy | Sham comparator | Firstly, 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. Receives: Device: tDCS + physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, after sessions, 30 and 90 days
Secondary outcomes (1)
Change from Motor Activity Log-30
MAL is a scripted, structured interview to measure real-world 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 teeth and picking up a glass. For a specified 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 ranges from 0 (never used) to 5 (same as pre-stroke). Scores average for activity frequency comprises the Amount of use scale (AOU); the mean of scores for how well the activity was performed comprises Quality of movement (QOM). Ideally, ratings are obtained from patient and as well as the caregiver.
Measured: baseline, after sessions, 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Kátia Monte-Silva, PhD, Study director, Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166619
- Sponsor's protocol ID
- ChronicStroke_tDCS_rehab
- Status last verified
- May 2014
- First submitted
- 14 Jun 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in Rehabilitation of Chronic Stroke Patients: Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT02166619
- Acronym / sponsor ID
- ChronicStroke_tDCS_rehab
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Electric stimulation therapy, Neuroplasticity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will undergo behavioral and electrophysiological evaluation before, immediately after, 30 and 90 days after 10 sessions (follow ups). They will be submitted to the following evaluations: (i) Fugl-Meyer Scale; (ii) Jebsen-Taylor hand functional test; (iii) Box-Block test; (iv) Motor Activity Log - 30; (v) Geriatric Depression Scale - 15; (vi) Beck Depression Inventory; (vii) Stroke Impact Scale; (viii) Hand Grip Strength and (iv) Modified Ashworth Scale. In addition, one question of motivation will be answered by patients in different stages of the treatment: (i) motivation regarding their own life at the beginning and ending of the treatment; (ii) daily motivation at the beginning of each session; (iii) motivation of the last week at the fifth and tenth sessions; (iv) motivation regarding their own life at 30 and 90 days after the ending of the treatment. A visual scale will be used to assess patient's motivation through five potential answers: "very little", "little", "more or less", "very much" and "extremely".
Electrophysiological measures will be performed before and after each session and in follow ups.
Evaluation of brain activity will be performed using single-pulse transcranial magnetic stimulation (TMS-p) only in Recife Centre. Magnetic stimulation (Neurosoft, Russia) will be applied through a figure-8 coil to determine motor cortex representation of first dorsal interosseus muscle (hotspot) and performed the following electrophysiological measures, in both cerebral hemispheres, to assess cortical activity: (i) Motor Evoked Potential (MEP); (ii) Active motor threshold (AMT) and (iii) Silent period (PS).
Evaluation of brain activity will be performed using single-pulse transcranial magnetic stimulation (TMS-p) only in Recife Centre. Magnetic stimulation (Neurosoft, Russia) will be applied through a figure-8 coil kept at a 45 degree angle relative to the sagittal line and pointed to the anterior region of the skull. Firstly, patients will be instructed to sit in a chair and to search a comfortable position. TMS-p will be applied in both motor cortex, healthy and injured, to determine the cortical representation of first dorsal interosseus muscle. The hotspot will be considered the most excitable area, with more intense motor evoked potential (MEP), measured by electromyography.
The following electrophysiological measures will be performed in both cerebral hemispheres to assess cortical activity:
(i) Motor Evoked Potential (MEP) : the intensity of magnetic stimulator is adjusted to produce an average MEP of 1.0 mV. TMS-p will be applied in the area of cortical representation of the first dorsal interosseous and mean responses to stimuli should reach 0.8 mV to 1.2 mV.
(ii) Active motor threshold (AMT) : will be request to the patient to perform contraction of the first interosseous muscle and then, will be given ten pulses by TMS-p to determinate active motor threshold. Motor threshold corresponds to the lowest intensity of TMS-p to produce a MEP of 50 μV in 50% of the pulses applied to the hotspot.
(iii) Silent period (PS) : is the interval of time that usually is observed absence of electromyographic activity. Occurs immediately after the registration of MEP during voluntary contraction of the target muscle (PEMvc - motor evoked potentials recorded during voluntary contraction). Higher the intensity of the magnetic stimulation, longer the duration of PS.
During tDCS application, patients will be seated in a comfortable chair with head and arms rests. Current will be applied by a DC stimulator (NeuroConn, Germany) using a pair of saline-soaked sponge electrodes (surface 24 cm²).
Bihemispheric tDCS will be applied to primary motor cortex (M1) in left and right hemispheres. These points correspond to C3 and C4 according to International 10-20 EEG system. Anode will be placed to M1 in affected hemisphere, while the cathode is positioned to M1 over the unaffected hemisphere. Parameters of current intensity and duration (dose) used were previously established in poststroke patients: 2 mA stimulation intensity for 20 minutes with current ramping up and down of 10 seconds each.
Sham tDCS has been used in several studies to evaluate the effect of active tDCS. In placebo stimulation, intensity and electrode's positions are the same as in the active group, however, current duration is only 30 seconds, with current ramping up and down of 10 seconds each. Moreover, the electrostimulation device is automatically turned off without patient's perception. Thus, patients experience early sensations (mild to moderate tingling) in stimulation site without inducing effect. Moreover, after each tDCS session, patients will answer adverse effects questionnaire.
After apply tDCS, 40 minutes of individual and intensive physical therapy session will be performed. Goals of the physical therapy protocol were discussed based in neuroplasticity principles by a group of experienced physiotherapists. Physical therapy activities will be focused on rehabilitation of upper limb and will cover the following purposes: flexibility, transfer and posture, coordination, balance and sensorial stimulation. Depending on patient's ability, a program of activities for each purpose will be adapted by a trained physical therapist.
The study will be conducted simultaneously in three research centers in Brazil: Applied Neuroscience Laboratory (LANA), Universidade Federal de Pernambuco (UFPE), Pernambuco, Brazil; D'Or Institute for Research and Education (ID'Or), Botafogo, Rio de Janeiro, Brazil and at the University Center Augusto Mota (UNISUAM), Bonsucesso Unit, Rio de Janeiro, Brazil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS + physical therapy | Experimental | Device: tDCS + physical therapyFirstly, 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 comparator | Device: tDCS + physical therapyFirstly, 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- Prior neurological diseases
- Multiple brain lesions
- Metal implant in the skull and face
- Pacemaker
- History of seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS + physical therapyAlso: non invasive brain stimulation, neuroConn (Germany)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 | Device | Sham tDCS + physical therapy, tDCS + physical therapy |
Primary outcome
Change in Fugl-Meyer assessment of paretic upper limb motor function
Time frame: baseline, after sessions, 30 and 90 days
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.
1 secondary outcome
Change from Motor Activity Log-30
Time frame: baseline, after sessions, 30 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
- Derived from this study: PubMed 33175411Elsner 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.
Related trials for Stroke
Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
Central Post-Stroke Pain, Stroke
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kátia Monte-Silva, PhD study director
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tDCS + physical therapy in people with Stroke, run by Universidade Federal de Pernambuco at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kátia Monte-Silva, PhD (+55 81 88631322, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer assessment of paretic upper limb motor function (time frame: baseline, after sessions, 30 and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014; AzTrials last refreshed its copy on 2 Nov 2026.