Effect of tACS on the Recovery of Motor Control of the Upper Limb and Cerebral Connectivity in Chronic Stroke Patients
NCT ID: NCT05947318
Last Updated: 2025-04-29
Study Results
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Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2023-05-02
2025-04-07
Brief Summary
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For this purpose, the experimental approach involves active (70 Hz in Gamma rhythm and 7 Hz, Theta rhythm) and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design.
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range, which enhances the upper limb motor recovery associated with a training program.
Using specific motor control parameters, clinical scales and electroencephalography, the immediate and long-term (3 months after finished the training) behavioral and neurophysiological effect of this new neurostimulation paradigm (tACS plus training) for motor rehabilitation of stroke will be established.
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Detailed Description
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Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range, which enhances the upper limb motor recovery associated with a training program.
The general objective is to assess the effects of a combined program of tACS and upper limb training on motor performance and brain connectivity in chronic-stage stroke patients.
The specifics objectives to accomplish this are (1) Implement a system for simultaneous measurement of motor activity and EEG under tACS, considering possible postural alterations in stroke patients. (2) Evaluate the upper limb motor control and neuronal synchrony associated with motor performance during the execution of a combined stimulation and training program. Training will include analytical and functional tasks to optimize the performance in function and activity ICF level. tACS will be applied only during analytical task. (3) Analyze the changes in motor performance and neuronal synchrony for the experimental groups.
Using specific motor control parameters (kinetic and kinematic control), clinical scales and electroencephalography, the immediate and long-term (3 months after finished the training) behavioral and neurophysiological effect of this new neurostimulation paradigm (tACS plus training) for motor rehabilitation of stroke will be established.
By means of analysis of variance, clustering comparisons and linear regressions, it will be established the effect of tACS on neuronal synchrony and the parallel motor activity, as well as their underlying relationship.
We will use the REDCap platform to register all the clinical data given by the medical record and clinical assessments.
The recruitment will be made at the Clinical Center of Metropolitan University of Educational Sciences and in the Primary Care Centers that are near to the University. The sample size is 45 chronic stage stroke survivors. The sample size calculation used the data available in the study for the difference in Fugl-Meyer score between the bihemispheric and sham transcranial Direct Current Stimulation groups after the intervention (in the study of Alisar et al, 2020), considering an effect size of 1.4, a p-value of 0.05 and a power (1- beta) of 0.9, which yielded a sample size of 12 subjects per group. Now, also considering an attrition percentage of 20% and an equivalence in the size of the 3 study groups, the final sample size is 15 people per group (45 people in total).
To answer the study hypothesis, two variables will be examined as primary results:
1. Behavioral level, it will be the score on the Fugl-Meyer scale (upper extremity section). This scale has been widely used in the field of neurorehabilitation to assess motor impairments (ICF function level).
2. Neurophysiological level, the primary outcome will be the change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks. Signal processing will follow a cluster approach using the Fieldtrip toolbox in Matlab software (R2016B).
Both variables will be subjected to a two-factor analysis of variance (experimental group factor (3 levels, tACS-70Hz, 7Hz and simulated) and time factor (4 levels referred to the measurement times)). Depending on the result, it will apply a post-hoc test (bonferroni) to study differences between levels and interactions. The association between the variables will be inspected through regression models. The level of significance will have a p-value of 0.05. The statistical analysis will be implemented in the R language and the Rstudio software. Complementary to the primary results, and in order to broaden the description of the study phenomenon, the scores of the clinical scales already described will be analyzed, as well as kinetic (absolute force, speed of force change) and kinematic variables (direction error, maximum speed) of the analytical and combined tasks. In addition, the long-scale synchrony will be described by means of connectivity variables between the electrodes already identified (phase locking value and weighted phase lag index).
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
1. tACS-70 Hz group
2. tACS-7Hz group
3. tACS-sham group
TREATMENT
TRIPLE
Study Groups
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tACS - 70 Hz group
The group will receive the training program plus 20 minutes of tACS at 70 Hz in the C3 or C4 electrode position (depending of the hemiparetic arm) during a specific kinetic and kinematic tasks in every training session.
transcranial alternating current stimulation 70 Hz
Transcranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side.
Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects.
The frequency stimulation will be 70 Hz
Training
Training of the upper limb with specific kinematic and kinetic tasks plus functional training
tACS - 7 Hz group
The group will receive the training program plus 20 minutes of tACS at 7 Hz in the C3 or C4 electrode position (depending of the hemiparetic arm) during a specific kinetic and kinematic tasks in every training session.
Training
Training of the upper limb with specific kinematic and kinetic tasks plus functional training
transcranial alternating current stimulation 7 Hz
Transcranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side.
Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects.
The frequency stimulation will be 7 Hz
tACS - sham group
The group will receive the training program plus 30 seconds of tACS at 70 Hz in the C3 or C4 electrode position (depending of the hemiparetic arm) in every training session.
Training
Training of the upper limb with specific kinematic and kinetic tasks plus functional training
transcranial alternating current stimulation Sham
Transcranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side.
Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects.
The stimulation will be turn on for 30 seconds (at 70 Hz)
Interventions
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transcranial alternating current stimulation 70 Hz
Transcranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side.
Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects.
The frequency stimulation will be 70 Hz
Training
Training of the upper limb with specific kinematic and kinetic tasks plus functional training
transcranial alternating current stimulation 7 Hz
Transcranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side.
Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects.
The frequency stimulation will be 7 Hz
transcranial alternating current stimulation Sham
Transcranial alternating current stimulation in the head above the motor cortex area of one side of the brain, according to the hemiparesis side.
Electrodes with 3.14 cm2 of stimulation area will be used, therefore, the initial current intensity will be 0.21 mA, with a current density of 0.07 mA / cm2. The current intensity will be adjusted to the tactile sensory threshold and phosphenes of each patient, with in order to reduce such sensory effects, but considering that the decrease in current will not be greater than 10% of the initial intensity, in order to obtain a comparable configuration between subjects.
The stimulation will be turn on for 30 seconds (at 70 Hz)
Eligibility Criteria
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Inclusion Criteria
* Upper Extremity -Fugl Meyer \> 10
* Wrist extensors strength of the paretic limb of 2 or more in the Medical Research Council (MRC) scale
* Active shoulder movement (flexion or abduction) of 30º or more
* Be able to follow the instructions necessary to achieve the training protocol
Exclusion Criteria
* Have some medical condition contraindicated for tACS (epilepsy, pacemaker, prosthesis between others)
* Have post-stroke epilepsy
* Limited passive range of motion in the elbow (less than 45º in flexo-extension plane)
* Limited passive range of motion in the wrist (less than 40º in flexo-extension plane)
* Limited passive range of motion in the shoulder (less than 70º in flexo-extension plane)
* Have another neurological condition that leads to upper extremity sequelae
* Have a normal performance in the clinical test
18 Years
80 Years
ALL
No
Sponsors
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Universidad Metropolitana de Ciencias de la Educacion
OTHER
Responsible Party
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Juan Jose Mariman Rivero
Full professor
Principal Investigators
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Juan J Mariman, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Universidad Metropolitana de Ciencias de la Educacion
Locations
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Centro de Habilidades Clínicas - Universidad Metropolitana de Ciencias de la Educación
Santiago, Santiago Metropolitan, Chile
Countries
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References
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Alisar DC, Ozen S, Sozay S. Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104454. doi: 10.1016/j.jstrokecerebrovasdis.2019.104454. Epub 2019 Nov 4.
Other Identifiers
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FONDECYT N° 11221226
Identifier Type: -
Identifier Source: org_study_id
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