StrokeNCT03452254
NIBS With mCIMT for Motor and Functional Upper Limb Recovery in Stroke Patients.
A study testing Active Bihemispheric Transcranial direct current Stimulation and Modified Constraint Induced Movement Therapy in people with Stroke and Upper Extremity Paresis, run by University of Chile at 2 sites in Chile.
Trial summary
Stroke is one of the leading causes of serious long-term impairment. According to the estimates, 12,500 people suffer a new or recurrent ischemic stroke in Chile annually, which shows the magnitude of the problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Upper Extremity Paresis, Electric Stimulation
- What is being tested?
- Active Bihemispheric Transcranial direct current Stimulation and Modified Constraint Induced Movement Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesChile
- Study dates
- 4 Jun 2018to 30 Jun 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First unihemispheric stroke event, ischemic or hemorrhagic, cortical or subcortical.
- Hemiparesis with unilateral brachial compromise.
- Evolution time ≥ 2 days. (equal or more than 2 days after onset)
- Patient must be 18 years old or older.
- Showing ability to perform some movement with the upper limb: at least 20º active extension of the wrist and 10º extension in fingers and/or 20° abduction angle in the shoulder.
- Informed consent signed by the patient.
Who cannot join
- Previous central injury with motor sequelae.
- Severe aphasia with a score ≥ 2 in the language item of the National Institutes of Health Stroke Scale assessment.
- Severe cognitive impairment with a score < 15 points in the Mini-mental state examination.
- Shoulder subluxation and/or pain > 4 points in the Visual Numeric Scale for pain.
- Non-controlled epilepsy or epileptic seizures in the last three months.
- Metal implants or pacemaker.
- Pregnancy.
- Any other condition that, in the responsible physician's opinion, could prevent the correct development of the treatment.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital San José
Santiago, Santiago Metropolitan, 8380419
Hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456
About this study
Official title: Non-invasive Brain Stimulation Combined With Modified Constraint Induced Movement Therapy for Motor and Functional Upper Limb Recovery of Patients With Sub-acute Stroke: Multicenter Randomized Clinical Trial
Stroke is one of the leading causes of serious long-term impairment. According to the estimates, 12,500 people suffer a new or recurrent ischemic stroke in Chile annually, which shows the magnitude of the problem. Motor impairment of the upper limb (UL) stands out as the principal sequel after a CVA (50% of the patients experience it), and the Constraint-Induced Movement Therapy (CIMT) is the rehabilitation approach that shows more scientific evidence today. Even though patients reach certain recuperation levels through this approach, results are still insufficient since 50-80% of the patients continue having upper limb motor impairment after completing standard rehabilitation. Because of this, it is pertinent to conduct research to explore new rehabilitation strategies to reduce the impairment indexes and to provide information for decision making based on evidence.
Recent studies on functional neuroimaging propose that there is an abnormal balance in the motor cortex excitability after stroke - relative under-excitability in the affected hemisphere and over-excitability in the unaffected hemisphere (with the consequent inhibitory influence on ipsilesional regions) in stroke patient with moderate motor impairment. This imbalance in the hemispheres function would limit the possibilities of a greater recovery. Then, in order to reestablish brain balance, the investigators proposed that the early introduction of noninvasive techniques of brain stimulation, such as tDCS, to the motor rehabilitation training could promote improvement of upper limb function in patients with stroke. However, we lack studies that confirm the benefits of using these techniques, define the most appropriate protocols, and determine what patients and under which evolving stages would be the best candidates for treatment.
This study aims to "compare the effectiveness of seven days of bi-hemispheric tDCS, both active and sham, combined with modified CIMT (mCIMT) in the motor and functional recovery of the hemiparetic upper limb in hospitalized patients with subacute unihemispheric stroke at Hospital Clínico de la Universidad de Chile and Hospital San José". This comparison responds to the hypothesis that patients who receive bi-hemispheric and active tDCS combined with mCIMT (experimental group) get at least 30% more recovery of the paretic upper limb compared to the control group who receive sham bi-hemispheric tDCS plus mCIMT after a protocol of seven days treatment.
Read the detailed description
To test this hypothesis, the investigators propose to carry out a sham randomized multicenter double blind clinical trial. This trial considers seven continuous days of treatment when the participants with hemiparesis as a result of a stroke will be assigned to one of the treatment groups: bi-hemispheric tDCS combined with mCIMT or bi-hemispheric sham tDCS combined with mCIMT. Besides collecting demographic and clinical info from the subjects, the investigators will assess the patients using upper limb scales of functional motor recovery and an evaluation of their functional independence in basic activities of daily living (ADLs). STATA 14.0 software will be used for data analysis.
To date, no study has tested the efficacy of early bi-hemispheric stimulation in combination with mCIMT in subacute hospitalized stroke patients.
- Being tested
- Active Bihemispheric Transcranial direct current Stimulation, Sham Bihemispheric Transcranial direct current Stimulation, Modified Constraint Induced Movement Therapy
- Keywords
- Stroke, Upper Extremity Paresis, Neuro Rehabilitation, tDCS, mCIMT, Occupational Therapy
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Bihemispheric Transcranial direct current StimulationDevice
Also called Active tDCS
The session will start with the application of the with a couple of surface sponge electrodes (25-35 cm2) on the scalp. The treatment modality will be as follows:
Active tDCS: The anodic electrode will be put on affected M1. The cathodic electrode will be put on contralateral M1. We will apply a constant current of 2mA of intensity during 20 minutes while the patient performs the occupational therapy session.
Sham Bihemispheric Transcranial direct current StimulationDevice
Also called Sham tDCS
The session will start with the application of the with a couple of surface sponge electrodes (25-35 cm2) on the scalp. The treatment modality will be as follows:
Sham tDCS: We will use the same place and parameters of stimulation applied for the active group, but the stimulator will deactivate after 30 seconds of stimulation. This will ensure that the patient will feel the initial tingling sensation at the beginning of the tDCS which is a requisite for blinding. The occupational therapy session will last one hour.
Modified Constraint Induced Movement TherapyOther
Also called mCIMT
Both groups will perform the mCIMT during a period of seven consecutive days. This protocol consists of two elements:
- Restriction of the movements of the non-affected hand by wearing a mitt during six hours a day: we will use a mitt that limits the movement of the fingers but allows the free movements of the wrist, elbow, and shoulder.
- Intensive and individualized training of the affected arm during 2 hours a day guided by an occupational therapist: the two hours training will be divided into two sessions of one hour each. Sessions will be organized in three blocks: preparation, activation, and function. In the third block, devoted to function, the patient has to choose one activity of daily living that he wants to improve.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | Active bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy. Receives: Device: Active Bihemispheric Transcranial direct current Stimulation; Other: Modified Constraint Induced Movement Therapy |
| Control Group | Sham comparator | Sham bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy. Receives: Device: Sham Bihemispheric Transcranial direct current Stimulation; Other: Modified Constraint Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Motor Recovery.
Percentage of the upper limb motor recovery after seven days treatment as assessed by Fugl Meyer Upper Extremity.
Measured: 7 days.
Upper Limb Functional Recovery.
Percentage of the upper limb functional recovery after seven days treatment as assessed by Wolf Motor Function Test.
Measured: 7 days.
Secondary outcomes (5)
Independence in basic activities of daily living.
Obtained score of independence in basic activities of daily living after seven days treatment as Assessed by Functional Independence Measure (FIM).
Measured: 10 days and 3 months later
Upper Limb Motor Recovery.
Percentage maintenance of the upper limb motor recovery after seven days treatment as Assessed by Fugl Meyer Upper Extremity.
Measured: 10 days and 3 months later
Upper Limb Functional Recovery.
Percentage maintenance of the upper limb functional recovery after seven days treatment as assessed by Wolf Motor Function Test.
Measured: 10 days
Quality of life post-stroke
Score in quality of life with stroke impact scale
Measured: At the third month
Brain activation patterns.
Effect on brain activation patterns of six patients after going through a protocol of seven days treatment.
Measured: 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start4 Jun 2018
- Primary completion30 Mar 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sham randomized multicenter double clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica, Hospital San José, Universidad Central de Chile, Sociedad Chilena de Medicina Física y Rehabilitación
- Responsible party
- Principal investigator, Maricel Garrido Montenegro, University of Chile
- Investigators
- Maricel A Garrido, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452254
- Sponsor's protocol ID
- 849/16
- Status last verified
- Sep 2021
- First submitted
- 26 Feb 2018
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still not decided.
Publications
Bjorklund A, Fecht A. The effectiveness of constraint-induced therapy as a stroke intervention: a meta-analysis. Occup Ther Health Care. 2006;20(2):31-49. doi: 10.1080/J003v20n02_03.
PubMed 23926912Konstan MW, Berger M. Current understanding of the inflammatory process in cystic fibrosis: onset and etiology. Pediatr Pulmonol. 1997 Aug;24(2):137-42; discussion 159-61. doi: 10.1002/(sici)1099-0496(199708)24:23.0.co;2-3.
PubMed 9292910Bolognini N, Pascual-Leone A, Fregni F. Using non-invasive brain stimulation to augment motor training-induced plasticity. J Neuroeng Rehabil. 2009 Mar 17;6:8. doi: 10.1186/1743-0003-6-8.
PubMed 19292910Butler AJ, Shuster M, O'Hara E, Hurley K, Middlebrooks D, Guilkey K. A meta-analysis of the efficacy of anodal transcranial direct current stimulation for upper limb motor recovery in stroke survivors. J Hand Ther. 2013 Apr-Jun;26(2):162-70; quiz 171. doi: 10.1016/j.jht.2012.07.002. Epub 2012 Sep 8.
PubMed 22964028Cramer SC. Repairing the human brain after stroke: I. Mechanisms of spontaneous recovery. Ann Neurol. 2008 Mar;63(3):272-87. doi: 10.1002/ana.21393.
PubMed 18383072Grefkes C, Fink GR. Reorganization of cerebral networks after stroke: new insights from neuroimaging with connectivity approaches. Brain. 2011 May;134(Pt 5):1264-76. doi: 10.1093/brain/awr033. Epub 2011 Mar 16.
PubMed 21414995Kandel M, Beis JM, Le Chapelain L, Guesdon H, Paysant J. Non-invasive cerebral stimulation for the upper limb rehabilitation after stroke: a review. Ann Phys Rehabil Med. 2012 Dec;55(9-10):657-80. doi: 10.1016/j.rehab.2012.09.001. Epub 2012 Sep 29. English, French.
PubMed 23084320Lavados PM, Sacks C, Prina L, Escobar A, Tossi C, Araya F, Feuerhake W, Galvez M, Salinas R, Alvarez G. Incidence, 30-day case-fatality rate, and prognosis of stroke in Iquique, Chile: a 2-year community-based prospective study (PISCIS project). Lancet. 2005 Jun 25-Jul 1;365(9478):2206-15. doi: 10.1016/S0140-6736(05)66779-7.
PubMed 15978929Page SJ, Levine P, Sisto S, Bond Q, Johnston MV. Stroke patients' and therapists' opinions of constraint-induced movement therapy. Clin Rehabil. 2002 Feb;16(1):55-60. doi: 10.1191/0269215502cr473oa.
PubMed 11837526Rehme AK, Grefkes C. Cerebral network disorders after stroke: evidence from imaging-based connectivity analyses of active and resting brain states in humans. J Physiol. 2013 Jan 1;591(1):17-31. doi: 10.1113/jphysiol.2012.243469. Epub 2012 Oct 22.
PubMed 23090951Shafi MM, Westover MB, Fox MD, Pascual-Leone A. Exploration and modulation of brain network interactions with noninvasive brain stimulation in combination with neuroimaging. Eur J Neurosci. 2012 Mar;35(6):805-25. doi: 10.1111/j.1460-9568.2012.08035.x.
PubMed 22429242Szaflarski JP, Page SJ, Kissela BM, Lee JH, Levine P, Strakowski SM. Cortical reorganization following modified constraint-induced movement therapy: a study of 4 patients with chronic stroke. Arch Phys Med Rehabil. 2006 Aug;87(8):1052-8. doi: 10.1016/j.apmr.2006.04.018.
PubMed 16876549Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.
PubMed 11994754Wagner T, Valero-Cabre A, Pascual-Leone A. Noninvasive human brain stimulation. Annu Rev Biomed Eng. 2007;9:527-65. doi: 10.1146/annurev.bioeng.9.061206.133100.
PubMed 17444810Singh P, Pradhan B. Study to assess the effectiveness of modified constraint-induced movement therapy in stroke subjects: A randomized controlled trial. Ann Indian Acad Neurol. 2013 Apr;16(2):180-4. doi: 10.4103/0972-2327.112461.
PubMed 23956560
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation Combined With Modified Constraint Induced Movement Therapy for Motor and Functional Upper Limb Recovery of Patients With Sub-acute Stroke: Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03452254
- Acronym / sponsor ID
- 849/16
- Keywords
- Stroke, Upper Extremity Paresis, Neuro Rehabilitation, tDCS, mCIMT, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica, Hospital San José, Universidad Central de Chile, Sociedad Chilena de Medicina Física y Rehabilitación
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 2 Mar 2018 (actual)
- 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.
Stroke is one of the leading causes of serious long-term impairment. According to the estimates, 12,500 people suffer a new or recurrent ischemic stroke in Chile annually, which shows the magnitude of the problem. Motor impairment of the upper limb (UL) stands out as the principal sequel after a CVA (50% of the patients experience it), and the Constraint-Induced Movement Therapy (CIMT) is the rehabilitation approach that shows more scientific evidence today. Even though patients reach certain recuperation levels through this approach, results are still insufficient since 50-80% of the patients continue having upper limb motor impairment after completing standard rehabilitation. Because of this, it is pertinent to conduct research to explore new rehabilitation strategies to reduce the impairment indexes and to provide information for decision making based on evidence.
Recent studies on functional neuroimaging propose that there is an abnormal balance in the motor cortex excitability after stroke - relative under-excitability in the affected hemisphere and over-excitability in the unaffected hemisphere (with the consequent inhibitory influence on ipsilesional regions) in stroke patient with moderate motor impairment. This imbalance in the hemispheres function would limit the possibilities of a greater recovery. Then, in order to reestablish brain balance, the investigators proposed that the early introduction of noninvasive techniques of brain stimulation, such as tDCS, to the motor rehabilitation training could promote improvement of upper limb function in patients with stroke. However, we lack studies that confirm the benefits of using these techniques, define the most appropriate protocols, and determine what patients and under which evolving stages would be the best candidates for treatment.
This study aims to "compare the effectiveness of seven days of bi-hemispheric tDCS, both active and sham, combined with modified CIMT (mCIMT) in the motor and functional recovery of the hemiparetic upper limb in hospitalized patients with subacute unihemispheric stroke at Hospital Clínico de la Universidad de Chile and Hospital San José". This comparison responds to the hypothesis that patients who receive bi-hemispheric and active tDCS combined with mCIMT (experimental group) get at least 30% more recovery of the paretic upper limb compared to the control group who receive sham bi-hemispheric tDCS plus mCIMT after a protocol of seven days treatment.
Detailed description
To test this hypothesis, the investigators propose to carry out a sham randomized multicenter double blind clinical trial. This trial considers seven continuous days of treatment when the participants with hemiparesis as a result of a stroke will be assigned to one of the treatment groups: bi-hemispheric tDCS combined with mCIMT or bi-hemispheric sham tDCS combined with mCIMT. Besides collecting demographic and clinical info from the subjects, the investigators will assess the patients using upper limb scales of functional motor recovery and an evaluation of their functional independence in basic activities of daily living (ADLs). STATA 14.0 software will be used for data analysis.
To date, no study has tested the efficacy of early bi-hemispheric stimulation in combination with mCIMT in subacute hospitalized stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sham randomized multicenter double clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Device: Active Bihemispheric Transcranial direct current Stimulation, Other: Modified Constraint Induced Movement TherapyActive bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy. |
| Control Group | Sham comparator | Device: Sham Bihemispheric Transcranial direct current Stimulation, Other: Modified Constraint Induced Movement TherapySham bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First unihemispheric stroke event, ischemic or hemorrhagic, cortical or subcortical.
- Hemiparesis with unilateral brachial compromise.
- Evolution time ≥ 2 days. (equal or more than 2 days after onset)
- Patient must be 18 years old or older.
- Showing ability to perform some movement with the upper limb: at least 20º active extension of the wrist and 10º extension in fingers and/or 20° abduction angle in the shoulder.
Key exclusion criteria (8 listed)
- Previous central injury with motor sequelae.
- Severe aphasia with a score ≥ 2 in the language item of the National Institutes of Health Stroke Scale assessment.
- Severe cognitive impairment with a score < 15 points in the Mini-mental state examination.
- Shoulder subluxation and/or pain > 4 points in the Visual Numeric Scale for pain.
- Non-controlled epilepsy or epileptic seizures in the last three months.
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 |
|---|---|---|
| Active Bihemispheric Transcranial direct current StimulationAlso: Active tDCSThe session will start with the application of the with a couple of surface sponge electrodes (25-35 cm2) on the scalp. The treatment modality will be as follows: Active tDCS: The anodic electrode will be put on affected M1. The cathodic electrode will be put on contralateral M1. We will apply a constant current of 2mA of intensity during 20 minutes while the patient performs the occupational therapy session. | Device | Experimental Group |
| Sham Bihemispheric Transcranial direct current StimulationAlso: Sham tDCSThe session will start with the application of the with a couple of surface sponge electrodes (25-35 cm2) on the scalp. The treatment modality will be as follows: Sham tDCS: We will use the same place and parameters of stimulation applied for the active group, but the stimulator will deactivate after 30 seconds of stimulation. This will ensure that the patient will feel the initial tingling sensation at the beginning of the tDCS which is a requisite for blinding. The occupational therapy session will last one hour. | Device | Control Group |
| Modified Constraint Induced Movement TherapyAlso: mCIMTBoth groups will perform the mCIMT during a period of seven consecutive days. This protocol consists of two elements: 1. Restriction of the movements of the non-affected hand by wearing a mitt during six hours a day: we will use a mitt that limits the movement of the fingers but allows the free movements of the wrist, elbow, and shoulder. 2. Intensive and individualized training of the affected arm during 2 hours a day guided by an occupational therapist: the two hours training will be divided into two sessions of one hour each. Sessions will be organized in three blocks: preparation, activation, and function. In the third block, devoted to function, the patient has to choose one activity of daily living that he wants to improve. | Other | Control Group, Experimental Group |
Primary outcome
Upper Limb Motor Recovery.
Time frame: 7 days.
Percentage of the upper limb motor recovery after seven days treatment as assessed by Fugl Meyer Upper Extremity.
Upper Limb Functional Recovery.
Time frame: 7 days.
Percentage of the upper limb functional recovery after seven days treatment as assessed by Wolf Motor Function Test.
5 secondary outcomes
Independence in basic activities of daily living.
Time frame: 10 days and 3 months later
Upper Limb Motor Recovery.
Time frame: 10 days and 3 months later
Upper Limb Functional Recovery.
Time frame: 10 days
Quality of life post-stroke
Time frame: At the third month
Brain activation patterns.
Time frame: 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Results publication: PubMed 23926912Bjorklund A, Fecht A. The effectiveness of constraint-induced therapy as a stroke intervention: a meta-analysis. Occup Ther Health Care. 2006;20(2):31-49. doi: 10.1080/J003v20n02_03.
- Results publication: PubMed 9292910Konstan MW, Berger M. Current understanding of the inflammatory process in cystic fibrosis: onset and etiology. Pediatr Pulmonol. 1997 Aug;24(2):137-42; discussion 159-61. doi: 10.1002/(sici)1099-0496(199708)24:23.0.co;2-3.
- Results publication: PubMed 19292910Bolognini N, Pascual-Leone A, Fregni F. Using non-invasive brain stimulation to augment motor training-induced plasticity. J Neuroeng Rehabil. 2009 Mar 17;6:8. doi: 10.1186/1743-0003-6-8.
- Results publication: PubMed 22964028Butler AJ, Shuster M, O'Hara E, Hurley K, Middlebrooks D, Guilkey K. A meta-analysis of the efficacy of anodal transcranial direct current stimulation for upper limb motor recovery in stroke survivors. J Hand Ther. 2013 Apr-Jun;26(2):162-70; quiz 171. doi: 10.1016/j.jht.2012.07.002. Epub 2012 Sep 8.
- Results publication: PubMed 18383072Cramer SC. Repairing the human brain after stroke: I. Mechanisms of spontaneous recovery. Ann Neurol. 2008 Mar;63(3):272-87. doi: 10.1002/ana.21393.
- Results publication: PubMed 21414995Grefkes C, Fink GR. Reorganization of cerebral networks after stroke: new insights from neuroimaging with connectivity approaches. Brain. 2011 May;134(Pt 5):1264-76. doi: 10.1093/brain/awr033. Epub 2011 Mar 16.
- Results publication: PubMed 23084320Kandel M, Beis JM, Le Chapelain L, Guesdon H, Paysant J. Non-invasive cerebral stimulation for the upper limb rehabilitation after stroke: a review. Ann Phys Rehabil Med. 2012 Dec;55(9-10):657-80. doi: 10.1016/j.rehab.2012.09.001. Epub 2012 Sep 29. English, French.
- Results publication: PubMed 15978929Lavados PM, Sacks C, Prina L, Escobar A, Tossi C, Araya F, Feuerhake W, Galvez M, Salinas R, Alvarez G. Incidence, 30-day case-fatality rate, and prognosis of stroke in Iquique, Chile: a 2-year community-based prospective study (PISCIS project). Lancet. 2005 Jun 25-Jul 1;365(9478):2206-15. doi: 10.1016/S0140-6736(05)66779-7.
- Results publication: PubMed 11837526Page SJ, Levine P, Sisto S, Bond Q, Johnston MV. Stroke patients' and therapists' opinions of constraint-induced movement therapy. Clin Rehabil. 2002 Feb;16(1):55-60. doi: 10.1191/0269215502cr473oa.
- Results publication: PubMed 23090951Rehme AK, Grefkes C. Cerebral network disorders after stroke: evidence from imaging-based connectivity analyses of active and resting brain states in humans. J Physiol. 2013 Jan 1;591(1):17-31. doi: 10.1113/jphysiol.2012.243469. Epub 2012 Oct 22.
- Results publication: PubMed 22429242Shafi MM, Westover MB, Fox MD, Pascual-Leone A. Exploration and modulation of brain network interactions with noninvasive brain stimulation in combination with neuroimaging. Eur J Neurosci. 2012 Mar;35(6):805-25. doi: 10.1111/j.1460-9568.2012.08035.x.
- Results publication: PubMed 16876549Szaflarski JP, Page SJ, Kissela BM, Lee JH, Levine P, Strakowski SM. Cortical reorganization following modified constraint-induced movement therapy: a study of 4 patients with chronic stroke. Arch Phys Med Rehabil. 2006 Aug;87(8):1052-8. doi: 10.1016/j.apmr.2006.04.018.
- Individual participant dataSharing planned: Undecided. Still not decided.
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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.
Maricel A Garrido principal investigator
University of Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Bihemispheric Transcranial direct current Stimulation and Modified Constraint Induced Movement Therapy in people with Stroke and Upper Extremity Paresis, run by University of Chile at 2 sites in Chile.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Motor Recovery. (time frame: 7 days.). The study lists 2 primary outcomes in all. 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 NCT03452254, which also lists 16 linked publications.
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 9 Sep 2021; AzTrials last refreshed its copy on 1 Nov 2026.