- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01879787
Effects of tDCS Combined With mCIMT or Mental Practice in Poststroke Patients
Impact of Transcranial Direct Current Stimulation (tDCS)on the Effects of Mental Practice and Modified Constraint-induced Movement Therapy (mCIMT)in the Rehabilitation of Chronic Stroke Patients
Study Overview
Detailed Description
Eighty-four patients chronic post-stroke will be recruited to participate in the study. After screening to check the eligibility criteria and giving informed consent, the patients will be randomized into seven distinct groups (12 per group). All the patients will be submitted to 12 therapeutic sessions that will occur with a frequency of three times a week.
Before, immediately after and 1 month after the beginning of the experimental sessions patients will be submitted to an evaluation at each moment will be applied: (i) Fugl- Meyer Scale, (ii) Motor Activity Log Scale, (iii ) Jebsen-Taylor hand functional test, (iv) Independence Functional Measure (v) Box-Block Test, (vi) Dynamometry and (vii) Berg Balance Scale.
In experimental sessions, the subjects always receive physiotherapy treatment with conventional techniques, the protocol will follow the guidelines outlined in Clinical Practice Guideline for physical therapy in stroke patients with the Royal Dutch Society for Physical Therapy (2004). Besides physical therapy, the patient may be subjected to transcranial direct current stimulation (tDCS) associated with the techniques of modified constraint-induced movement therapy (mCIMT) or mental practice (MP).
tDCS protocol During tDCS sessions, the patients will be seated in a comfortable chair with head and arm rests. Continuous direct current will be applied by clinical microcurrent stimulator (Soterix, USA) using a pair of saline-soaked surface sponge electrodes (surface 35 cm2). For anodal and sham stimulation (the polarity refers always to the motor cortical electrode), the anode electrode will be placed over primary motor cortex (M1; EEG 10/20 system) of the affected hemisphere and cathode above contralateral orbit. For cathodal tDCS, the cathode will be positioned over M1 of the non-affected hemisphere and the anode was placed above the contralateral orbit. For bi-hemispheric tDCS the anode electrode will be placed over M1 of the affected hemisphere and the cathode over the M1 of the healthy hemisphere. Transcranial direct current stimulation will be administered with a current strength of 1 mA for 13 (anodal/bi-hemispheric tDCS) or 9 min (cathodal tDCS). Sham tDCS will be performed by current flow for 30 s, a method shown to achieve a good level of blinding mCIMT protocol The modified CIMT consisted of (i) complete immobilization of the non-paretic upper limb and (ii) intensive training the paretic upper limb and will be administered by a trained therapist, who was not involved in the pre-post evaluations.
Continuously for six hours daily over a period of four weeks, including weekend, all patients will be remained with complete immobilization of the non paretic upper limb. For this, an arm sling with the shoulder in adduction and internal rotation, elbow flexed at 90º, wrist and fingers in neutral position, made specifically for each patient will be used. They will be advised to use the restriction during their daily activities and instructed to remove it every hour for 10 minutes to perform stretching, which has been previously taught by the researchers to avoid functional deterioration caused by disuse. All muscle groups of the upper extremity will be stretched. A guide with instructions of the stretching will be distributed to patients. The patients will be instructed to take the immobilization on every day at same hour the tDCS sessions. In addition, the patients will be allowed to take the arm sling off during activities in which safety would be compromised, such as toileting, dressing, and bathing.
For intensive training the paretic upper limb, the patients will attend a gross motor and fine motor activities program performed for 1 hour per day, three times per week. Each task was performed for 2-3 minutes and the rest interval between tasks will be determined for each subject in order to avoid fatigue and excessive tiredness. The tasks will be progressively adapted by increasing speed or accuracy to allow improvement of patient performance. All tasks will be done with subjects sitting on a chair with standard dimensions and performed on support table. During training sessions, the patients will remain with the non-paretic arm immobilized.
Mental practice protocol Prior to experimental sessions, the mental capacity of subjects to learn the imagery techniques will be tested by the Kinesthetic and Visual Imagery Questionnaire and a chronometric test. The Kinesthetic and Visual Imagery Questionnaire is an imagery assessment tool comprised of 10 items, each scored on a five-point ordinal scale, including the image clarity (visual dimension) and the sensations intensity (kinesthetic dimension) of body movements. Each item describes an action: (i) neck flexion/extension, (ii) shoulder shrugging, (iii) forward trunk flexion, (iv) forward shoulder flexion, (v) elbow flexion, (vi) thumb to finger tips, (vii) knee extension, (viii) hip abduction, (ix) foot external rotation, and (x) foot tapping. Subjects physically execute each movement and immediately afterwards imagine performing the same movement. A score of 5 corresponds to the highest clarity/intensity, and a score of 1 corresponds to the lowest clarity/ intensity (for a review, see Malouin et al., 2007). The Kinesthetic and Visual Imagery Questionnaire scores allowed the researcher to assess each participant's abilities and decide whether the subject was a suitable candidate for MP. Comparing actual and imagined movement times, the chronometric test determined the motor imagery ability of participants.
The mental practice will consist of motor imagination of tasks. These tasks will consist of action for the patient to imagine themselves, with the greatest wealth of detail possible, performing motor activities with the hemiparetic upper limb, such as the movement of the touching thumb on each other's toes hand, or even the movement of bringing a cup towards his mouth. The technique of mental practice will be applied at the same time of the tDCS.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50740-560
- Applied Neuroscience Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- chronic stroke (> 6 months)
- score ≥ 20 at the Folstein Mini Mental State Examination
- score ≤ 3 at the Ashworth Scale
- score ≤ 4 at the Visual Analog Pain Scale
Exclusion Criteria:
- multiple brain lesions
- medication for treatment of spasticity
- attention deficit
- deficit in perceptual ability and motivation to follow the instructions for the mental training
- pregnant
- pacemaker
- metal implant in the region of the skull and face
- history of convulsion
- epilepsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: physiotherapy + anodal tDCS + mCIMT
Before a anodal tDCS with duration of 13 minutes and intensity of 1mA applied at the injured motor cortex, the patient will be submitted to a 30 minutes physiotherapy protocol.
Lastly the individual will realized a 45 minutes mCIMT protocol.
The experimental sessions will be repeated three times per week, will be realized 10 sessions.
At home the patient will spend 6 hours per day with the restraint for the paretic upper limb.
|
tDCS involves application of very low-amplitude direct currents(2 mA or less) via surface scalp electrodes.This produces a sub-sensory level of electrical stimulation which remains imperceptible by most people during its application.
In a small percentage of patients it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds.
The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability.
Depending on the polarity of active electrodes tDCS can increase or decrease corticomotor excitability.
Cathodal tDCS decrease and anodal tDCS increase the motor cortex excitability.
Other Names:
|
Experimental: Physiotherapy + cathodal tDCS + mCIMT
Before a cathodal tDCS with duration of 9 minutes and intensity of 1mA applied at the healthy motor cortex, the patient will be submitted to a 30 minutes physiotherapy protocol.
Lastly the individual will realized a 45 minutes mCIMT protocol.
The experimental sessions will be repeated three times per week, will be realized 10 sessions.
At home the patient will spend 6 hours per day with the restraint for the paretic upper limb.
|
tDCS involves application of very low-amplitude direct currents(2 mA or less) via surface scalp electrodes.This produces a sub-sensory level of electrical stimulation which remains imperceptible by most people during its application.
In a small percentage of patients it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds.
The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability.
Depending on the polarity of active electrodes tDCS can increase or decrease corticomotor excitability.
Cathodal tDCS decrease and anodal tDCS increase the motor cortex excitability.
Other Names:
|
Experimental: Physiotherapy+bi-hemispheric tDCS+mCIMT
Before a bi-hemispheric tDCS with duration of 13 minutes and intensity of 1mA applied at the healthy (cathode) and injured (anode) motor cortex, the patient will be submitted to a 30 minutes physiotherapy protocol.
Lastly the individual will realized a 45 minutes mCIMT protocol.
The experimental sessions will be repeated three times per week, will be realized 10 sessions.
At home the patient will spend 6 hours per day with the restraint for the paretic upper limb.
|
tDCS involves application of very low-amplitude direct currents(2 mA or less) via surface scalp electrodes.This produces a sub-sensory level of electrical stimulation which remains imperceptible by most people during its application.
In a small percentage of patients it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds.
The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability.
Depending on the polarity of active electrodes tDCS can increase or decrease corticomotor excitability.
Cathodal tDCS decrease and anodal tDCS increase the motor cortex excitability.
Other Names:
|
Sham Comparator: Physiotherapy+sham tDCS+mCIMT
Before a sham tDCS with duration of 30 seconds and intensity of 1mA applied at the injured motor cortex, the patient will be submitted to a 30 minutes physiotherapy protocol.
Lastly the individual will realized a 45 minutes mCIMT protocol.
The experimental sessions will be repeated three times per week, will be realized 10 sessions.
At home the patient will spend 6 hours per day with the restraint for the paretic upper limb.
|
tDCS involves application of very low-amplitude direct currents(2 mA or less) via surface scalp electrodes.This produces a sub-sensory level of electrical stimulation which remains imperceptible by most people during its application.
In a small percentage of patients it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds.
The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability.
Depending on the polarity of active electrodes tDCS can increase or decrease corticomotor excitability.
Cathodal tDCS decrease and anodal tDCS increase the motor cortex excitability.
Other Names:
|
Experimental: Physiotherapy+tDCS+mental practice
Before a tDCS protocol applied during de mental practice training , the patient will be submitted to a 30 minutes physiotherapy protocol.
The experimental sessions will be repeated three times per week, will be realized 10 sessions.
|
tDCS involves application of very low-amplitude direct currents(2 mA or less) via surface scalp electrodes.This produces a sub-sensory level of electrical stimulation which remains imperceptible by most people during its application.
In a small percentage of patients it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds.
The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability.
Depending on the polarity of active electrodes tDCS can increase or decrease corticomotor excitability.
Cathodal tDCS decrease and anodal tDCS increase the motor cortex excitability.
Other Names:
|
Sham Comparator: Physiotherapy+sham tDCS+mental practice
Before a sham tDCS protocol applied during the mental practice training, the patient will be submitted to a 30 minutes physiotherapy protocol.
The experimental sessions will be repeated three times per week, will be realized 10 sessions.
|
tDCS involves application of very low-amplitude direct currents(2 mA or less) via surface scalp electrodes.This produces a sub-sensory level of electrical stimulation which remains imperceptible by most people during its application.
In a small percentage of patients it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds.
The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability.
Depending on the polarity of active electrodes tDCS can increase or decrease corticomotor excitability.
Cathodal tDCS decrease and anodal tDCS increase the motor cortex excitability.
Other Names:
|
No Intervention: Physiotherapy
The patient will be submitted to a 30 minutes physiotherapy protocol.
The experimental sessions will be repeated three times per week, will be realized 10 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Fugl-Meyer Assessment of Upper Extremity Motor Function
Time Frame: At baseline, 1 month and 2 month
|
The Fugl-Meyer assessment was used to measure recovery of motor control.
It is a 226-point scoring system that includes range of motion, pain, sensation, motor function of the upper and lower extremities, and balance.This instrument provides a reliable and valid measure of specific motor function that is also sensitive to change.
|
At baseline, 1 month and 2 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Motor Activity Log
Time Frame: At baseline, 1 month and 2 month
|
The MAL is a scripted, structured interview to measure real-world upper extremity function.
It was developed to measure the effects of therapy on the more impaired arm following stroke.
The original MAL consists of 14 activities of daily living (ADLs) such as using a towel, brushing teeth, and picking up a glass.
For a specified time period post-stroke, the individual is asked about the extent of the activity performed and how well it was performed by the more impaired arm.
The response scale ranges from 0 (never used) to 5 (same as pre-stroke).
The mean of the scores for frequency of the activity comprises the Amount of Use (AOU) scale; the mean of the scores for how well the activity was performed comprises the Quality of Movement (QOM) scale.
Ideally, ratings are obtained from the individual with a stroke as well as a knowledgeable informant (caregiver).
|
At baseline, 1 month and 2 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Jebsen-Taylor Hand Function Test
Time Frame: At baseline, 1 month and 2 months
|
The Jebsen-Taylor function test was designed to provide a short, objective test of hand functions commonly used in activities of daily living (ADLs).
The target patient population includes adults with neurological or musculoskeletal conditions involving hand disabilities, although there may be other patient populations with other hand dysfunctions which may be appropriate.
The test was developed to be used by health professionals working in restoration of hand function.
It consists of seven items that include a range of fine motor, weighted and non-weighted hand function activities
|
At baseline, 1 month and 2 months
|
Collaborators and Investigators
Investigators
- Study Director: Kátia K Monte Silva, PhD, Universidade Federal de Pernambuco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- tDCS_mCIMT_MP_Stroke
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 tDCS
-
Hôpital le VinatierCompletedSchizophrenia | Auditory HallucinationsFrance, Tunisia
-
Universidad de AlmeriaSecretaría General de Universidades, Investigación y Tecnología, Junta de...Enrolling by invitationSubstance-Related DisordersSpain
-
Nachum Soroker, MDUnknown
-
Bambino Gesù Hospital and Research InstituteCompleted
-
Northeastern UniversityMassachusetts General Hospital; National Institute on Aging (NIA)Unknown
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedMotor Activity | Motor NeuroplasticityUnited States
-
Charite University, Berlin, GermanyCompletedMigraine With Aura | CADASIL | Cerebral Microangiopathy | ICA StenosisGermany
-
Universidade Federal de PernambucoCompleted
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)Completed
-
Thorsten RudroffTerminatedMultiple Sclerosis | Neuropathic PainUnited States