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

Etude Pilote Randomisee Versus Placebo Evaluant l'Efficacite de la Stimulation Electrique Transcranienne de Faible Intensite (Tdcs) Dans le Soulagement de la Dyspnee Chez Les Patients Sous Ventilation Mecanique en Reanimation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mechanical Ventilation Complication; Dyspnea
• Intervention / Treatment: Device: Placebo; Device: Anodal; Device: Cathodal

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Hôpital Raymond Poincaré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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; 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.
Experimental: Anodal tDCS; 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; 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.
Experimental: Cathodal tDCS; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death		28 days
ICU length of stay		28 days
Differential of the QS	Assessing differentials of the QS of the Multidimensional Dyspnea Profile measured between before and after the tDCS (MPD-QS scales) between before (30 min before) and after (30 min after) the use of tDCS.	30 min
Differential of the A2 dimension	Assessing differentials of the sale A2 of the Multidimensional Dyspnea Profile measured between before and after the tDCS (MPD-A2 scales) between before (30 min before) and after (30 min after) the use of tDCS.	30 min
Differential of IC-RDOS	Differential of Diagnostic Accuracy of Respiratory Distress Observation Scales (IC-RDOS scale) between before (30 min before) and after (30 min after) the use of tDCS. Persichini, R., Gay, F., Schmidt, M., Mayaux, J., Demoule, A., Morélot-Panzini, C., & Similowski, T. (2015). Diagnostic accuracy of respiratory distress observation scales as surrogates of dyspnea self-report in intensive care unit patients. Anesthesiology: The Journal of the American Society of Anesthesiologists, 123(4), 830-837.	30 min
Pre-inspiratory potentials (PIP)	Presence of possible PIP on Electroencephalography (EEG)	1 day
Delirium	Cumulative incidence of delirium and its duration	28 days
Mechanical ventilation	Cumulative incidence of mechanical ventilation	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
mouth pressure	differences of mouth pressure between before (30 min before) and after (30 min after) the use of tDCS	30 min
respiratory rate	differences of respiratory rate between before (30 min before) and after (30 min after) the use of tDCS	30 min
tidal volume	differences of tidal volume between before (30 min before) and after (30 min after) the use of tDCS	30 min

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Actual): May 9, 2020
• Study Completion (Anticipated): January 9, 2022

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: K160904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No