TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
NCT ID: NCT06204627
Last Updated: 2024-05-16
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-09-30
2024-12-01
Brief Summary
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Non-invasive neuromodulation, such as transcranial direct current stimulation (TDCS), allows modulating cortical excitability and promoting pain relief.
This study intends to verify the effects of the association of noninvasive brain stimulation with TDCS with an intervention with visual and motor stimuli related to laterality in patients with neck pain.
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Detailed Description
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1. active TDCS associated with laterality recognition stimuli (n = 25);
2. active TDCS associated with landscape recognition stimuli (n = 25);
3. TDCS sham associated with laterality recognition stimuli (n = 25);
4. TDCS sham associated with landscape recognition stimuli (n = 25);
Eight induction sessions will be held twice a week for four weeks. Patients who present a positive response in the first reassessment (responders) will remain in the study follow-up and will undergo a weekly maintenance session, for four weeks, and two more biweekly sessions.
The following instruments will be used for evaluation: motor safety thresholds through a MagVenture pulse generator with a flat surface coil, figure 8; OPAL, device with sensors; Recognize™ application; Visual Analog Scale (VAS); Brief Pain Inventory (BDI); Clinical Global Impression - ICG (patient and evaluated version); Pain McGill Standard Questionnaire - Short Format; Hospital Anxiety and Depression Scale (HAD); 36-item summary health survey from the Medical Outcomes Study (SF-36); Mini best test; neurodynamic tests (upper limb tension tests); and quantitative sensory tests. In addition to the pre- and post-intervention assessments, there will be post-treatment follow-up performed three, six and 12 months after randomization by telephone or e-mail. It is expected that the combined application of tDCS with stimuli related to laterality will have positive effects in patients with neck pain, impacting on variables such as pain, functional movements and quality of life of these patients.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
1. active TDCS associated with laterality recognition stimuli (n = 25);
2. active TDCS associated with landscape recognition stimuli (n = 25);
3. TDCS sham associated with laterality recognition stimuli (n = 25);
4. TDCS sham associated with landscape recognition stimuli (n = 25).
TREATMENT
TRIPLE
Study Groups
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Active bipolar TDCS associated with laterality recognition stimuli
Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Individuals with active bipolar TDCS will receive a 2mA stimulus for twenty minutes. Meanwhile, they will use the Regognise hand application to discriminate right/left side of hand images.
TDCS
Technique of non-invasive brain stimulation by direct current (TDCS) which involves the modulation of excitability and brain activity, capable of promoting reorganization of the cortical representation of the body schema or motor planning, and consequently, pain relief.
Recognize (hand) - Laterality
This technique stimulates the ability to recognize hand images as right/left quicklPatients with chronic pain present delayed recognition of hand laterality, which is related to the duration of symptoms and the pain evoked by the execution of the movement. Thus, this technique can have beneficial effects in breaking the pain.
Active bipolar TDCS associated with landscape recognition stimuli
Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Individuals with active bipolar TDCS will receive a 2mA stimulus for twenty minutes.
At the same time, they will be guided to recognize landscapes that do not refer to the recognition of laterality.
TDCS
Technique of non-invasive brain stimulation by direct current (TDCS) which involves the modulation of excitability and brain activity, capable of promoting reorganization of the cortical representation of the body schema or motor planning, and consequently, pain relief.
Landscape recognition
Image recognition training that does not refer to right/left discrimination.
Sham TDCS associated with laterality recognition stimuli
Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Stimulation will remain inactive for the 20 minutes. Meanwhile, they will use the Regognise hand app to discriminate right/left hand images.
Recognize (hand) - Laterality
This technique stimulates the ability to recognize hand images as right/left quicklPatients with chronic pain present delayed recognition of hand laterality, which is related to the duration of symptoms and the pain evoked by the execution of the movement. Thus, this technique can have beneficial effects in breaking the pain.
Sham TDCS
TDCS sham: The device remains inactive for 20 minutes.
Sham TDCS associated with landscape recognition stimuli
Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Stimulation will remain inactive for the 20 minutes. At the same time, they will be guided to recognize landscapes that do not refer to the recognition of laterality.
Sham TDCS
TDCS sham: The device remains inactive for 20 minutes.
Landscape recognition
Image recognition training that does not refer to right/left discrimination.
Interventions
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TDCS
Technique of non-invasive brain stimulation by direct current (TDCS) which involves the modulation of excitability and brain activity, capable of promoting reorganization of the cortical representation of the body schema or motor planning, and consequently, pain relief.
Recognize (hand) - Laterality
This technique stimulates the ability to recognize hand images as right/left quicklPatients with chronic pain present delayed recognition of hand laterality, which is related to the duration of symptoms and the pain evoked by the execution of the movement. Thus, this technique can have beneficial effects in breaking the pain.
Sham TDCS
TDCS sham: The device remains inactive for 20 minutes.
Landscape recognition
Image recognition training that does not refer to right/left discrimination.
Eligibility Criteria
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Inclusion Criteria
* pain in the cervical region, lasting more than three months and with intensity greater than 40/100 on the visual analog scale
Exclusion Criteria
* history of head trauma,
* intracranial hypertension,
* intracranial metal clip,
* pregnant or breastfeeding women,
* skin lesions at the current application site;
* changes in sensitivity and allergy in the electrode positioning region.
* intermittent pain;
* Cancer;
* cardiac pacemaker;
* severe spinal diseases, such as recent fractures or ankylosing spondylitis;
* serious cardiorespiratory diseases;
* participants who refuse to sign the Free and Informed Consent Form.
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Clarice Tanaka
Director, Principal investigator
Locations
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Universidade de São Paulo
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Clarice Tanaka, PhD
Role: primary
Other Identifiers
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94350518.6.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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