Upper Limb Tremor InvalidatingNCT02883738
Evaluation the Effect of Muscle Functional Electrical Stimulation in the Upper Limb Tremor Invalidating
A study testing tremor in people with Upper Limb Tremor Invalidating, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The main objective of this study is to identify the superficial muscle groups involved in gene-related tremor and assess the reduction in the intensity of the tremor after transient electrical stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Limb Tremor Invalidating
- What is being tested?
- tremor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Dec 2013
- 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
- Subject with disabling tremor of upper limb
- Subject with essential tremor action and / or lesion
Who cannot join
- Subject with drug tremor
- Subject presenting an exaggerated physiological tremor
- Subject with isolated resting tremor
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to identify the superficial muscle groups involved in gene-related tremor and assess the reduction in the intensity of the tremor after transient electrical stimulation.
- Conditions
- Upper Limb Tremor Invalidating
- Being tested
- tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tremorOther
evaluation of the intensity of the tremor
| Study group | Role | What they receive |
|---|---|---|
| upper limb tremor | Experimental | Not described Receives: Other: tremor |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the intensity of tremor by measuring the hand moving speed (mm / s)
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMar 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Tremor InvalidatingStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883738
- Sponsor's protocol ID
- 8188
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Muscle Functional Electrical Stimulation in the Upper Limb Tremor Invalidating
- ClinicalTrials.gov ID
- NCT02883738
- Acronym / sponsor ID
- 8188
- Conditions
- Upper Limb Tremor Invalidating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Aug 2016 (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 main objective of this study is to identify the superficial muscle groups involved in gene-related tremor and assess the reduction in the intensity of the tremor after transient electrical stimulation.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| upper limb tremor | Experimental | Other: tremor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject with disabling tremor of upper limb
- Subject with essential tremor action and / or lesion
Key exclusion criteria (3 listed)
- Subject with drug tremor
- Subject presenting an exaggerated physiological tremor
- Subject with isolated resting tremor
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 |
|---|---|---|
| tremorevaluation of the intensity of the tremor | Other | upper limb tremor |
Primary outcome
evaluation of the intensity of tremor by measuring the hand moving speed (mm / s)
Time frame: at 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 30 Aug 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tremor in people with Upper Limb Tremor Invalidating, run by University Hospital, Montpellier 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 2 inclusion and 3 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 30 Aug 2016. 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?
evaluation of the intensity of tremor by measuring the hand moving speed (mm / s) (time frame: at day 0). 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 30 Aug 2016.