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| ID | Type | Description | Link |
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| U1111-1306-808 | Other Identifier | Universal Test Number (UTN) |
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| Name | Class |
|---|---|
| Financiadora de Estudos e Projetos | OTHER |
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Amyotrophic Lateral Sclerosis (ALS) is a nervous system disease that causes muscle weakness and rapidly progresses to the loss of mobility and functionality. Studies suggest that High-Definition Transcranial Direct Current Stimulation (HD-tDCS) is a technique for modulating motor cortical hyperexcitability. However, evidence on the use of HD-tDCS as a neuromodulator of the diaphragmatic motor cortex in people with ALS is inconclusive.
A multicenter, randomized controlled clinical trial will be conducted. Participants will be randomized into two groups: the HD-tDCS group (gTDCS) and the sham tDCS group (gSham). The intervention protocol will assess the effects of HD-tDCS on respiratory parameters and ALS progression. The study will include individuals of both sexes, aged 18 to 80 years, with a clinical diagnosis of ALS, evaluated before, during, and after the home-based HD-tDCS protocol. The electrodes will be positioned in a circular arrangement over the primary diaphragmatic motor cortex, applying a continuous anodal current intensity. For placebo comparison, only an initial 30-second ramp stimulus will be applied, followed by a minimal current, resulting in no significant intervention. The intervention will be conducted at the participant's home, once daily, five days per week, for two weeks. Patients will undergo evaluations of lung function, cough peak flow, respiratory muscle strength, nasal respiratory pressures, functional capacity, muscle fatigue, cognitive function, as well as surface electromyography of respiratory muscles during active and assisted breathing curves using transcranial magnetic stimulation (TMS), cortical excitability, central tissue oxygenation, respiratory muscle tissue oxygenation, functionality and disease progression, motor control and muscle performance, fatigue and dyspnea, sleep analysis, quality of life, and adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active HD-tDCS Group | Experimental | Patients randomly included in this group will receive 10 sessions of anodal HD-tDCS stimulation. The intervention will take place at the participant's home, with electrodes positioned in a circular arrangement-one central electrode and four peripheral electrodes-over the cortical representation zone of the left primary diaphragmatic motor cortex, with a continuous current applied |
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| HD-tDCS sham group | Placebo Comparator | Patients randomly included in this group will receive 10 sessions of sham HD-tDCS stimulation. The intervention will take place at the participant's home, with electrodes positioned in a circular arrangement-one central electrode and four peripheral electrodes-over the cortical representation zone of the left primary diaphragmatic motor cortex. Only an initial 30-second ramp stimulus will be applied, followed by a non-effective current |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active HD-tDCS | Device | 10 sessions of anodal HD-tDCS stimulation (neurostimulator coupled with a 4x1 HD-tDCS multichannel adapter) with a defined electrical current intensity over the cortical representation zone of the left diaphragmatic motor cortex |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical excitability assessed via TMS | Cortical excitability assessed by means of Transcranial Magnetic Stimulation measuring motor evoked potentials, cortical inhibition and duration of the cortical silent period | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Cortical tissue oxygenation | Assessment of cortical tissue oxygenation using brain coupled near-infrared spectroscopy technique coupled to the brain to monitor cerebral oxygenation and regional cerebral oxygen saturation. | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Electromyographic activity of specific respiratory muscles | This outcome will be assessed through Electromyography of the sternocleidomastoid, scalene, parasternal, hemidiaphragm and rectus abdominis muscles | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory function assessed by spirometry | This outcome will be assessed using spirometry | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Maximum Inspiratory and Expiratory Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guilherme A. F Fregonezi, PhD | Contact | +55(84)99426-7896 | guilherme.fregonezi@ufrn.br | |
| Edna K. F Laurentino, MSc | Contact | +55(84)99471-5172 | ednakarlaferreira@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
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| Universidade de Brasília - Campus Ceilândia | Recruiting | Brasília | Federal District | 72220-275 | Brazil |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
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Parallel Assignment
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| Simulated HD-tDCS | Device | 10 sessions of sham anodal HD-tDCS stimulation (neurostimulator coupled with a 4x1 HD-tDCS multichannel adapter) over the cortical representation zone of the left diaphragmatic motor cortex. The device will provide a 30-second ramp and then maintain a minimal, non-effective continuous current |
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This outcome will be assessed by assessing maximum inspiratory and expiratory pressure, Sniff Nasal Inspiratory Pressure and Sniff Nasal Expiratory Pressure curves
| From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Cough Peak Flow | This outcome will be assessed through Cough Peak Flow values | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Respiratory muscle oxygenation via near-infrared spectroscopy | This outcome will be assessed using the near-infrared spectroscopy technique coupled to the scalene and parasternal muscles | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Peripheral upper limb muscle activity assessed via electromyography | This outcome will be assessed through a protocol for assessing muscle activity positioned in the Lower Trapezius, Anterior Deltoid, Biceps Brachii (medial head), Triceps Brachii (lateral head), Brachioradialis, Extensor Carpi Radialis Longus, Abductor Pollicis Brevis and Upper Trapezius muscles, bilaterally | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Functionality and disease progression | This outcome will be assessed using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised which has 12 items with a score from zero to 4, and its total score can range from zero to 48, where 48 means normal functionality and zero, severe disability | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Fatigue Severity | This outcome will be assessed using the Fatigue Severity Scale comprises nine statements ranging from 1 to 7, with 7 being the maximum level of agreement with the statement, with a minimum score of 9 and a maximum of 63, with values equal to or greater than 28 indicating fatigue | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Dyspnea assessed via Modified Borg Scales | The Modified Borg scale is numbered from 0 to 10, with each number referring to a textual description of the degree of respiratory fatigue, with 0 as the minimum and 10 as the maximum respiratory discomfort | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Quality of sleep assessment | This outcome will be assessed using the Mini-Sleep Questionnaire | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Quality of life assessed using the Brief ALS-specific Quality of Life Questionnaire | This outcome will be assessed using the Brief Specific Quality of Life Questionnaire for ALS Patients | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| Subjective assessment of stimulation-related effects | This outcome will be assessed through a questionnaire about effects such as itching, tingling, redness of the skin, drowsiness, concentration problems, headache, fatigue, dizziness and others, indicating the intensity of these sensations on a scale of 1 to 4 (1 being none, 2 being mild, 3 being moderate and 4 being strong) and whether these effects are related to the stimulation, using a Likert scale from 1 (no relation) to 5 (strongly related) | From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up) |
| PneumoCardioVascular Lab - HUOL/UFRN | Recruiting | Natal | Rio Grande do Norte | 59010-090 | Brazil |
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| Universidad Autónoma de Chile | Not yet recruiting | Santiago | Santiago Metropolitan | 7500912 | Chile |
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| Universidad do Chile | Not yet recruiting | Santiago | Santiago Metropolitan | 8380453 | Chile |
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| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |