- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07354607
Effect of Transcutaneous Electrical Stimulation on Peripheral Blood Flow (VASC-STIM)
Effect of Transcutaneous Electrical Stimulation on Peripheral Blood Flow - a Pilot Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: leo blervaque
- Phone Number: +33 4 79 96 59 10
- Email: leo.blervaque@ch-metropole-savoie.fr
Study Locations
-
-
-
Chambéry, France, 73000
- Recruiting
- Centre Hospitalier Metropole Savoie
-
Contact:
- leo blervaque
- Phone Number: +33479965910
- Email: leo.blervaque@ch-metropole-savoie.fr
-
Contact:
- florence jego, ARC
- Phone Number: +33479965910
- Email: florence.jego@ch-metropole-savoie.fr
-
Principal Investigator:
- Cloé Seynaeve
-
Sub-Investigator:
- laurent messonnier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Participant unable to comply with the specific procedures of the study.
- Participant deprived of liberty or benefiting from legal protection measures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
transcutaneous electrical nerve stimulation
|
transcutaneous electrical nerve stimulation on arm.
6 different protocol will be apply testing different modality of frequency and positionnement of electrodes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stimulation parameters that induce the most significant hyperaemic response
Time Frame: from enrollment to the end of the procedure (1h30)
|
Determine the stimulation parameters (frequency in the range 5- 100Hz and proximal or distal placement) that induce the most significant hyperaemic response in volunteers.
|
from enrollment to the end of the procedure (1h30)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the score on a scale of disconfort level during stimulation for each condition
Time Frame: during testing procedure
|
The outcome will be assess using a visual analogic disconfort scale ranging from 0 (no disconfort) to 10 (the highest disconfort imaginable).
|
during testing procedure
|
|
Compare stimulation intensities between each condition
Time Frame: during testing procedure
|
during testing procedure
|
|
|
Compare muscle metabolic demand between each condition
Time Frame: during testing procedure
|
during testing procedure
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
during testing procedure (second visit)
|
|
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)
|
during testing procedure (second visit)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHMS25010
- 2025-A02335-44 (Other Identifier: RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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