Randomized Study Evaluating the Efficacy of Low Intensity Transcranial Electrical Stimulation (Tdcs) for the Relief of Dyspnea (tDCS-DYSP-REA)

Assistance Publique - Hôpitaux de Paris

Status and phase: Unknown; Phase 2

Conditions: Dyspnea; Mechanical Ventilation Complication

Treatments: Device: Placebo; Device: Cathodal; Device: Anodal

Study type: Interventional

Funder types: Other

Identifiers

NCT03640455

K160904

Details and patient eligibility

About

Nearly half (47%) of patients with mechanical ventilation in the intensive care unit report having dyspnea. This respiratory distress, with a feeling of "thirst for air", often reaches unbearable limits and is a major factor in the deterioration of the quality of life and the prognosis of patients. Physiopathological mechanisms of dyspnea are beginning better understood and have analogies with those of pain. Like pain, dyspnea often persists despite appropriate treatment of the cause, because of perceptual dysfunction related to changes in cortical excitability and neuronal plasticity and requires specific treatments. Studies have shown that Transcranial Stimulation by low Current (tDCS) was able to modulate the perception of acute pain induced and chronic pain. The tDCS modulates the functioning of a whole set of brain structures including the anterior cingulate gyrus, the prefrontal cortex, the thalamus and the brain stem, some of which have an established role in the central integration of pain and dyspnea. The investigators have recently demonstrated that the application of tDCS on the primary cortical motor area reduces the excitability of the central neurological pathways dedicated to the respiratory muscles in healthy subjects. The investigators therefore hypothesize that tDCS could relieve dyspnea in intensive care. In this research project, the investigators propose to evaluate the efficiency of tDCS on dyspnea in patients admitted to intensive care unit, having sepsis and mechanically ventilated.

Enrollment: 63 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient, hospitalized in intensive care unit, presenting a sepsis, having required a mechanical ventilation since at least 24h.
• Non-sedated or showing good wake up (Richmond Agitation-Sedation Scale score (RASS)> -3 at inclusion (Sessler et al., 2002)) within 48 hours after cessation of sedation
• Patient able to answer by "yes" or "no" to simple questions
• Showing significant dyspnea (level ≥ 4) on the A1 sub-scale of the Multidimensional Dyspnea Profile (MPD-A1 ≥ 4).
• Signature of informed consent by the patient or his relative.

Exclusion criteria

• Patient under guardianship,
• Wake up delay, coma (GCS ≤ 8), or severe agitation.
• chronic respiratory pathology
• respiratory pathology, neuromuscular or neuro-sensory disability (auditory or visual).
• Cranioplasty
• Language barrier, refusal to participate in the study or to sign the informed consent,
• Pregnant or nursing woman,
• No affiliation to a social security scheme.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

A tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; dummy stimulation will be given.

Treatment:

Device: Placebo

Anodal tDCS

Experimental group

Description:

A tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; Current Transcranial Stimulation (intensity 2 mA) will be given in anodal polarity.

Treatment:

Device: Anodal

Cathodal tDCS

Experimental group

Description:

A tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; Current Transcranial Stimulation (intensity 2 mA) will be given in cathodal polarity.

Treatment:

Device: Cathodal