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HD-tDCS in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial

ConditionAmyotrophic Lateral Sclerosis (ALS)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversidade Federal do Rio Grande do Norte

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Active HD-tDCS GroupExperimental treatment 1 intervention
Group B: HD-tDCS sham groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
2

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.

Time frame
From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
3

Electromyographic activity of specific respiratory muscles

This outcome will be assessed through Electromyography of the sternocleidomastoid, scalene, parasternal, hemidiaphragm and rectus abdominis muscles

Time frame
From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)

Secondary outcomes

1

Respiratory function assessed by spirometry

This outcome will be assessed using spirometry

Time frame
From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
2

Maximum Inspiratory and Expiratory Pressure

This outcome will be assessed by assessing maximum inspiratory and expiratory pressure, Sniff Nasal Inspiratory Pressure and Sniff Nasal Expiratory Pressure curves

Time frame
From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
3

Cough Peak Flow

This outcome will be assessed through Cough Peak Flow values

Time frame
From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
4

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

Time frame
From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Federal do Rio Grande do Norte

Lead sponsor

Financiadora de Estudos e Projetos

Collaborator

Source ClinicalTrials.gov
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