AmputationTH-IMESNCT03644394
Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees
A study testing Implantation of IMES sensors in people with Amputation, run by Medical University of Vienna.
Trial summary
The Implantable Myoelectric Sensors (IMES) system is an investigational device intended to improve signal quality and consistency of myoelectric signals for prosthetic control in individuals suffering from an above elbow (transhumeral) amputation. Read more about this study
- Who is it for?
- Ages 16 to 70 years, men only
- Conditions the study is for
- Amputation
- What is being tested?
- Implantation of IMES sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Oct 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 16 to 70 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unilateral transhumeral amputation
- can speak and comprehend German
- undergone amputee rehabilitation, including being trained to wear and use a conventional myoelectric prosthesis
- residual upper limb meets the criterions for TMR surgery
Who cannot join
- Known genetic neuromuscular disorder
- bleeding or clotting disorder
- active implant
- any metal fragments or metal implants located within the residual upper limb stump
- Female patients if pregnant or breast-feeding
About this study
The Implantable Myoelectric Sensors (IMES) system is an investigational device intended to improve signal quality and consistency of myoelectric signals for prosthetic control in individuals suffering from an above elbow (transhumeral) amputation. The sensors pick up myoelectric signals intramuscularly and therefore signal quality is not affected from electrode replacement, perspiration, or artefacts.
Read the detailed description
Implantable Myoelectric Sensors (IMES), the surgical tools implantation, and the external equipment used to control an electromechanical prosthetic device, together comprise the IMES System (investigational product, medical device).
Each IMES acts as an independent differential amplifier consisting of custom electronics housed within a biocompatible, hermetically sealed ceramic cylinder with metal end caps. The end caps serve as electrodes for picking up EMG activity during muscle contraction. Reverse telemetry (via a coil around the arm) is used to transfer data from the implanted sensor, and forward telemetry is used to transmit power and configuration settings to the sensors. The coil and associated electronics are housed within the frame of a prosthesis. A control system that sends data associated with muscle contraction to the motors of the prosthetic joints is housed in a belt-worn, battery-powered device. A cable attaches the control unit to the prosthetic frame.
An IMES is implanted into each targeted muscle that will be used to control a function of the prosthetic arm. Two IMES devices are needed for each DOF. For example, one device would control fingers opening and another device would control fingers closing.
- Conditions
- Amputation
- Being tested
- Implantation of IMES sensors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of IMES sensorsDevice
Surgical implantation of IMES sensors during routine surgery to improve prosthetic control
| Study group | Role | What they receive |
|---|---|---|
| Implantation | Other | Surgical Implantation of IMES sensors Receives: Device: Implantation of IMES sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hand function over time
Southampton Hand Assessment Procedure
Measured: at 3, 6, 9 and 12 months after final prosthetic fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study startAug 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Salminger, Medical University of Vienna
- Investigators
- Christian Hofer, PhD, Study chair, Otto Bock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644394
- Sponsor's protocol ID
- 1320/2014
- Acronym
- TH-IMES
- Status last verified
- Aug 2018
- First submitted
- 11 Aug 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study including all results is already submitted to be published
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees
- ClinicalTrials.gov ID
- NCT03644394
- Acronym / sponsor ID
- TH-IMES / 1320/2014
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Aug 2018 (actual)
- 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 Implantable Myoelectric Sensors (IMES) system is an investigational device intended to improve signal quality and consistency of myoelectric signals for prosthetic control in individuals suffering from an above elbow (transhumeral) amputation. The sensors pick up myoelectric signals intramuscularly and therefore signal quality is not affected from electrode replacement, perspiration, or artefacts.
Detailed description
Implantable Myoelectric Sensors (IMES), the surgical tools implantation, and the external equipment used to control an electromechanical prosthetic device, together comprise the IMES System (investigational product, medical device).
Each IMES acts as an independent differential amplifier consisting of custom electronics housed within a biocompatible, hermetically sealed ceramic cylinder with metal end caps. The end caps serve as electrodes for picking up EMG activity during muscle contraction. Reverse telemetry (via a coil around the arm) is used to transfer data from the implanted sensor, and forward telemetry is used to transmit power and configuration settings to the sensors. The coil and associated electronics are housed within the frame of a prosthesis. A control system that sends data associated with muscle contraction to the motors of the prosthetic joints is housed in a belt-worn, battery-powered device. A cable attaches the control unit to the prosthetic frame.
An IMES is implanted into each targeted muscle that will be used to control a function of the prosthetic arm. Two IMES devices are needed for each DOF. For example, one device would control fingers opening and another device would control fingers closing.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation | Other | Device: Implantation of IMES sensorsSurgical Implantation of IMES sensors |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral transhumeral amputation
- can speak and comprehend German
- undergone amputee rehabilitation, including being trained to wear and use a conventional myoelectric prosthesis
- residual upper limb meets the criterions for TMR surgery
Key exclusion criteria (5 listed)
- Known genetic neuromuscular disorder
- bleeding or clotting disorder
- active implant
- any metal fragments or metal implants located within the residual upper limb stump
- Female patients if pregnant or breast-feeding
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 |
|---|---|---|
| Implantation of IMES sensorsSurgical implantation of IMES sensors during routine surgery to improve prosthetic control | Device | Implantation |
Primary outcome
Change in hand function over time
Time frame: at 3, 6, 9 and 12 months after final prosthetic fitting
Southampton Hand Assessment Procedure
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 2018.
- Individual participant dataSharing planned: No. The study including all results is already submitted to be published
Related trials for Amputation
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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.
Christian Hofer, PhD study chair
Otto Bock
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of IMES sensors in people with Amputation, run by Medical University of Vienna.
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 4 inclusion and 5 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 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in hand function over time (time frame: at 3, 6, 9 and 12 months after final prosthetic fitting). 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 2018.