Alcohol Withdrawal SyndromeRESCNCT02146716
Assessment of Energetic Resonance by Cutaneous Stimulation on Withdrawal Alcohol Symptoms.
A study testing Energetic Resonance by Cutaneous Stimulation in people with Alcohol Withdrawal Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to measure the benzodiazepine amount prescribed during the withdrawal time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcohol Withdrawal Syndrome
- What is being tested?
- Energetic Resonance by Cutaneous Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 80 years,
- Patient with alcohol addiction,
- Patient needing alcohol withdrawal in a hospital.
- Patient with social Security,
- Patient with inform consent signed.
Who cannot join
- Pregnant women
- Minor.
- Major with guardianship.
- People without sufficient information because of troubles of cognitive functions, or without sufficient knowledge of French language.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to measure the benzodiazepine amount prescribed during the withdrawal time.
- Conditions
- Alcohol Withdrawal Syndrome
- Being tested
- Energetic Resonance by Cutaneous Stimulation
- Keywords
- RESC, alcohol withdrawal syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energetic Resonance by Cutaneous StimulationOther
Energetic Resonance by Cutaneous Stimulation (RESC) is a non-invasive method based on energetic Chinese medicine principles and digital contact. RESC is characterized by echo phenomena between two stimulation points.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Energetic Resonance by Cutaneous Stimulation | Experimental | Energetic Resonance by Cutaneous Stimulation session in addition to standard treatment for patients with withdrawal alcohol symptoms. Receives: Other: Energetic Resonance by Cutaneous Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cushman Score measure after Energetic Resonance by Cutaneous Stimulation
CUSHMAN score is represented by a scale with 7 variables collecting physiological modifications or behavioural manifestations related to adrenergic answer, neurovegetative signs, confusion, nervousness, perceptive or hallucinatory phenomena.
Measured: daily during one week
Secondary outcomes (4)
Anxiety depression scale
Measured: pre-screening, day 3 and day 7
prescribed benzodiazepine amount
Measured: day 0 to day 7
Analogic Visual Scale
Measured: before and after each Energetic Resonance by Cutaneous Stimulationsession at day 2, day 4 and day 6.
Quality of life scale
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Augustin-Normand, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146716
- Sponsor's protocol ID
- 2013-840
- Acronym
- RESC
- Status last verified
- Aug 2017
- First submitted
- 19 May 2014
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Energetic Resonance by Cutaneous Stimulation on Withdrawal Alcohol Symptoms.
- ClinicalTrials.gov ID
- NCT02146716
- Acronym / sponsor ID
- RESC / 2013-840
- Conditions
- Alcohol Withdrawal Syndrome
- Keywords
- RESC, alcohol withdrawal syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to measure the benzodiazepine amount prescribed during the withdrawal time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Energetic Resonance by Cutaneous Stimulation | Experimental | Other: Energetic Resonance by Cutaneous StimulationEnergetic Resonance by Cutaneous Stimulation session in addition to standard treatment for patients with withdrawal alcohol symptoms. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between 18 and 80 years,
- Patient with alcohol addiction,
- Patient needing alcohol withdrawal in a hospital.
- Patient with social Security,
- Patient with inform consent signed.
Key exclusion criteria (4 listed)
- Pregnant women
- Minor.
- Major with guardianship.
- People without sufficient information because of troubles of cognitive functions, or without sufficient knowledge of French language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energetic Resonance by Cutaneous StimulationEnergetic Resonance by Cutaneous Stimulation (RESC) is a non-invasive method based on energetic Chinese medicine principles and digital contact. RESC is characterized by echo phenomena between two stimulation points. | Other | Energetic Resonance by Cutaneous Stimulation |
Primary outcome
Cushman Score measure after Energetic Resonance by Cutaneous Stimulation
Time frame: daily during one week
CUSHMAN score is represented by a scale with 7 variables collecting physiological modifications or behavioural manifestations related to adrenergic answer, neurovegetative signs, confusion, nervousness, perceptive or hallucinatory phenomena.
4 secondary outcomes
Anxiety depression scale
Time frame: pre-screening, day 3 and day 7
prescribed benzodiazepine amount
Time frame: day 0 to day 7
Analogic Visual Scale
Time frame: before and after each Energetic Resonance by Cutaneous Stimulationsession at day 2, day 4 and day 6.
Quality of life scale
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
Related trials for Alcohol Withdrawal Syndrome
RecruitingPhase 2/3
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Withdrawal
RecruitingPhase 2/3
Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
Alcohol Use Disorder (AUD), Withdrawal From Addictive Substance; Detoxification
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
Not yet recruiting
Preventox - a Digital Intervention for Patients With Intoxications in Intensive Care
Intoxication, Delirium Tremens (DTs)
Not yet recruiting
Prevention of Relapse Through Cognitive Cycling in Patients With Alcohol Use Disorder Following Alcohol Withdrawal
Cognitive Cycling, Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Augustin-Normand, Dr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energetic Resonance by Cutaneous Stimulation in people with Alcohol Withdrawal Syndrome, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cushman Score measure after Energetic Resonance by Cutaneous Stimulation (time frame: daily during one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.