Effect of Transcutaneous Electrical Stimulation on Peripheral Blood Flow

ConditionsVolunteerAdult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Metropole Savoie

About this trial

The goal of this clinical trial is to learn if transcutaneous electrical nerve stimulation can affect blood flow in healthy volunteers. The main question it aims to answer is:

Determine the stimulation parameters (frequency in the range 5- 100Hz and proximal or distal placement) inducing the most significant hyperaemic response in volunteers.

Participants will attend to one visit ( 1h30) , 6 protocol of stimulation will be tested on his arm . If his agree, an optionnal measure will be made during another visit. During this optionnal visit, two modalities of intensity adjustment will be tested in regard of the result of the first part of the study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subject aged 18 years or older

Having freely given written consent, after being informed of the purpose of the study, its conduct and its risks.

Affiliated with a social security scheme

Disqualifiers

Persons with pacemakers or any other implantable electrical devices,

Pregnant women

Suffering from dermatological conditions or muscle/skin lesions on the arms and forearms.

Participant unable to give free and informed consent.

Trial design

Design model

Single group

Treatments tested in this trial

  • transcutaneous electrical nerve stimulation

    Other intervention

    transcutaneous electrical nerve stimulation on arm. 6 different protocol will be apply testing different modality of frequency and positionnement of electrodes

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

stimulation parameters that induce the most significant hyperaemic response

Determine the stimulation parameters (frequency in the range 5- 100Hz and proximal or distal placement) that induce the most significant hyperaemic response in volunteers.

Time frame
from enrollment to the end of the procedure (1h30)

Secondary outcomes

1

Assess the score on a scale of disconfort level during stimulation for each condition

The outcome will be assess using a visual analogic disconfort scale ranging from 0 (no disconfort) to 10 (the highest disconfort imaginable).

Time frame
during testing procedure
2

Compare stimulation intensities between each condition

Time frame
during testing procedure
3

Compare muscle metabolic demand between each condition

Time frame
during testing procedure

Other outcomes

1

ancillary : Compare blood flow kinetics during long-term stimulation (1 hour) according to the modalities of intensity adjustment over time (no adjustment vs. adjustment).

Time frame
during testing procedure (second visit)
2

ancillary : Compare the comfort reported by participants during long-term stimulation based on the methods used to adjust intensity over time (no adjustment vs. adjustment).

Time frame
during testing procedure (second visit)

Sponsors and contacts

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

Centre Hospitalier Metropole Savoie

Lead sponsor

Laboratoire Interuniversitaire de Biologie de la Motricité

Collaborator

Université Savoie Mont Blanc

Collaborator