Stroke Clinical Trial
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
NCT number | NCT03452254 |
Other study ID # | 849/16 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 4, 2018 |
Est. completion date | June 30, 2021 |
Verified date | September 2021 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | June 30, 2021 |
Est. primary completion date | March 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Clinico Universidad de Chile | Santiago | Metropolitana |
Chile | Hospital San José | Santiago | Metropolitana |
Lead Sponsor | Collaborator |
---|---|
University of Chile | Comisión Nacional de Investigación Científica y Tecnológica, Hospital San José, Sociedad Chilena de Medicina Física y Rehabilitación, Universidad Central de Chile |
Chile,
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. — View Citation
Bolognini 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. Review. — View Citation
Butler 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 — View Citation
Cramer 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. Review. — View Citation
Grefkes 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. Review. — View Citation
Kandel 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. Review — View Citation
Konstan 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. — View Citation
Lavados 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. 2 — View Citation
Page 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. — View Citation
Rehme 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. Review. — View Citation
Shafi 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. Rev — View Citation
Singh 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. — View Citation
Szaflarski 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. — View Citation
Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. Review. — View Citation
Wagner T, Valero-Cabre A, Pascual-Leone A. Noninvasive human brain stimulation. Annu Rev Biomed Eng. 2007;9:527-65. — View Citation
Wu CY, Chen CL, Tang SF, Lin KC, Huang YY. Kinematic and clinical analyses of upper-extremity movements after constraint-induced movement therapy in patients with stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2007 Aug;88(8):964-70. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Upper Limb Motor Recovery. | Percentage of the upper limb motor recovery after seven days treatment as assessed by Fugl Meyer Upper Extremity. | 7 days. | |
Primary | Upper Limb Functional Recovery. | Percentage of the upper limb functional recovery after seven days treatment as assessed by Wolf Motor Function Test. | 7 days. | |
Secondary | 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). | 10 days and 3 months later | |
Secondary | Upper Limb Motor Recovery. | Percentage maintenance of the upper limb motor recovery after seven days treatment as Assessed by Fugl Meyer Upper Extremity. | 10 days and 3 months later | |
Secondary | Upper Limb Functional Recovery. | Percentage maintenance of the upper limb functional recovery after seven days treatment as assessed by Wolf Motor Function Test. | 10 days | |
Secondary | Quality of life post-stroke | Score in quality of life with stroke impact scale | At the third month | |
Secondary | Brain activation patterns. | Effect on brain activation patterns of six patients after going through a protocol of seven days treatment. | 7 days. |
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