An interventional study of Active Bihemispheric Transcranial direct current Stimulation and Sham Bihemispheric Transcranial direct current Stimulation in Stroke, Upper Extremity Paresis and Electric Stimulation, sponsored by University of Chile. Completed at 2 sites in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by University of Chile · Not applicable, Interventional, and Treatment
Among 48 studies in Stroke with a site in Chile — 7 open to participants now, 7 under way, none of them phase 3. Stroke · Chile.
Among the 48 studies in Stroke with a site in Chile, this one is the 22nd largest by enrollment of the 35 interventional ones that give a count, is one of 5 that started in 2018, is one of 18 with no phase, and was the 28th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 70 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →7 of the 48 studies in Stroke with a site in Chile are open now, in 6 countries. Each count lists the studies.
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →48 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 5 started in 2018.
Median enrollment 270 across the 35 interventional studies, 626 across the 13 observational. Of the 39 that completed or were terminated, 15 (38%) have results posted.
20 of 48 have an industry lead sponsor. The 10 most frequent:
University of Chile is the lead sponsor of 194 studies on the registry; 38 are open to participants now.
University of Chile has 6 studies filed under Stroke — fewer than ten, so there is no comparison to draw.
1 of the studies in Stroke with a site in Chile that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06496529University of ChileExoDoF: Robotic Exoskeleton for Upper Limb Motor Rehabilitation After Stroke | 2027-06-30 |
Among the 48 studies in Stroke with a site in Chile, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy.
Device: Active Bihemispheric Transcranial direct current Stimulation · Other: Modified Constraint Induced Movement Therapy
Sham bi-hemispheric transcranial Direct Current Stimulation combined with modified Constraint Induced Movement Therapy.
Device: Sham Bihemispheric Transcranial direct current Stimulation · Other: Modified Constraint Induced Movement Therapy
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.
Also known as: 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: 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.
Also known as: Sham tDCS
Both 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.
Also known as: mCIMT
Upper Limb Motor Recovery.
Percentage of the upper limb motor recovery after seven days treatment as assessed by Fugl Meyer Upper Extremity.
Time frame: 7 days.
Upper Limb Functional Recovery.
Percentage of the upper limb functional recovery after seven days treatment as assessed by Wolf Motor Function Test.
Time frame: 7 days.
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).
Time frame: 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.
Time frame: 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.
Time frame: 10 days
Quality of life post-stroke
Score in quality of life with stroke impact scale
Time frame: At the third month
Brain activation patterns.
Effect on brain activation patterns of six patients after going through a protocol of seven days treatment.
Time frame: 7 days.
Plan to share: Undecided — Still not decided.
Ran from Jun 2018 to primary completion in Mar 2021, 33 months.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 33 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.