Evaluation the Effect of Muscle Functional Electrical Sti... | NCT02883738

Studies
Evaluation the Effect of Muscle Functional Electrical Stimulation in the Upper Limb Tremor Invalidating

NCT02883738

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Aug 30, 2016Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Upper Limb Tremor Invalidating

Interventions

tremor

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 9, 2016

First Submission Date that Met QC Criteria

Aug 24, 2016

First Posted Date

Aug 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2016

Last Update Posted Date

Aug 30, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
upper limb tremor	Experimental		Other: tremor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tremor	Other	evaluation of the intensity of the tremor	upper limb tremor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluation of the intensity of tremor by measuring the hand moving speed (mm / s)		at day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject with disabling tremor of upper limb
Subject with essential tremor action and / or lesion

Exclusion Criteria:

Subject with drug tremor
Subject presenting an exaggerated physiological tremor
Subject with isolated resting tremor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gui de Chauliac Hospital		Montpellier		34090	France