Clinical trial NCT06719947: HD-tDCS in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial
Official title: High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic Lateral Sclerosis (ALS)
Central Nervous System Diseases
Electric Stimulation Therapy
Transcranial Direct Current Stimulation
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
Collaborators: name: Financiadora de Estudos e Projetos
First posted: 2024-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Both sexes; diagnosis of ALS according to the revised El Escorial criteria;
* Age between 18 and 80 years;
* Forced Vital Capacity greater than 50% of predicted;
* Sniff nasal inspiratory pressure greater than 40 cmH2O;
* A telephone number to contact the care team and who signed the study consent form.

Exclusion Criteria:

* Subjects who are unable to understand or perform any of the study procedures;
* Subjects who do not agree to participate or voluntarily request withdrawal from the study at any time;
* Subjects with cardiac, respiratory, or musculoskeletal comorbidities;
* Subjects using invasive mechanical ventilation;
* Subjects with a tracheostomy;
* Subjects with a pacemaker;
* Subjects with metallic brain implants or other electronic implants;
* Subjects with a cochlear implant;
* Subjects with epileptic activity or a history of epilepsy, or a family history of epilepsy;
* Subjects with a history of stroke or tumor;
* Subjects prone to severe hemodynamic fluctuations, acute infectious processes, and/or inflammatory conditions;
* Pregnant women at the time of recruitment;
* Subjects who are unable to complete the intervention protocol.

Primary outcomes:
measure: Cortical excitability assessed via TMS
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Cortical tissue oxygenation
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Electromyographic activity of specific respiratory muscles
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Secondary outcomes:
measure: Respiratory function assessed by spirometry
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Maximum Inspiratory and Expiratory Pressure
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Cough Peak Flow
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Respiratory muscle oxygenation via near-infrared spectroscopy
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Peripheral upper limb muscle activity assessed via electromyography
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Functionality and disease progression
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Fatigue Severity
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Dyspnea assessed via Modified Borg Scales
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Quality of sleep assessment
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Quality of life assessed using the Brief ALS-specific Quality of Life Questionnaire
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
measure: Subjective assessment of stimulation-related effects
timeFrame: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Universidade de Brasília - Campus Ceilândia
state: DF
city: Natal
country: Brazil
facility: PneumoCardioVascular Lab - HUOL/UFRN
state: RN
city: Santiago
country: Chile
facility: Universidad Autónoma de Chile
state: Región Metropolitana
city: Santiago
country: Chile
facility: Universidad do Chile
state: Región Metropolitana
Study officials:
References: