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

NCT03640455 | Unknown Phase 2 DMC

• 1 other identifier: K160904
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyspnea; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• Differential of the Dyspnea

  Assessing differential of the Dyspnea Multidimensional Profile (MPD-A1) Scale A1 (from 0 to 10): between before (30 min before) and after (30 min after) the use of tDCS. The scale name is " Multidimensional dyspnea profile". The A1 dimension will be used and measures affective dimensions unpleasantness and overall breathing discomfort. The minimum score is 0 ( neutral) and the maximum score is 10 (unbearable discomfort).

  30 min

Secondary Outcomes (8)

• Differential of the QS

  30 min

• Differential of the A2 dimension

  30 min

• Differential of IC-RDOS

  30 min

• Pre-inspiratory potentials (PIP)

  1 day

• Death

  28 days

Other Outcomes (3)

• mouth pressure

  30 min

• respiratory rate

  30 min

• tidal volume

  30 min

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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.

Device: Placebo

Anodal tDCS

EXPERIMENTAL

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.

Device: Anodal

Cathodal tDCS

EXPERIMENTAL

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.

Device: Cathodal

Interventions

Placebo DEVICE

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; placebo (dummy stimulation), according to the patient's randomization arm.

Placebo

Anodal DEVICE

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; intensity 2 mA, in anodal polarity, according to the patient's randomization arm.

Anodal tDCS

Cathodal DEVICE

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; intensity 2 mA, in cathodal polarity, according to the patient's randomization arm.

Cathodal tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient, hospitalized in intensive care unit, presenting a sepsis, having required a mechanical ventilation since at least 24h.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Raymond Poincaré

Garches, 92380, France

Location

Related Publications (1)

• Azabou E, Bao G, Heming N, Bounab R, Moine P, Chevallier S, Chevret S, Resche-Rigon M, Siami S, Sharshar T, Lofaso F, Annane D. Randomized Controlled Study Evaluating Efficiency of Low Intensity Transcranial Direct Current Stimulation (tDCS) for Dyspnea Relief in Mechanically Ventilated COVID-19 Patients in ICU: The tDCS-DYSP-COVID Protocol. Front Med (Lausanne). 2020 Jun 26;7:372. doi: 10.3389/fmed.2020.00372. eCollection 2020.

  PMID: 32671084 DERIVED

MeSH Terms

Conditions

Dyspnea

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 21, 2018
• Study Start: November 9, 2018
• Primary Completion: May 9, 2020
• Study Completion: January 9, 2022
• Last Updated: November 22, 2021

Record last verified: 2021-11

Locations

FR (1)