Hand DeformitiesPhase 1NCT00628537
Prevention of Post-Stroke Hand/Wrist Flexion Deformity
A Phase 1 study testing BION stimulation in people with Hand Deformities, run by University of Southern California at 1 site in United States.
Trial summary
The study looks at a new treatment for wrist and finger contractures -- a condition where the affected hand is in a "closed" position, with the wrist and fingers stiff and difficult to move from that position. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hand Deformities
- What is being tested?
- BION stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2008
- Phase
- Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hemiplegic stroke 6 months to 20 years prior to enrollment in this study;
- Paresis of extensors in the forearm;
- Demonstrable restriction of hand or wrist mobility (i.e. significant stretch response, defined as a 2+ or greater on the Ashworth scale, can be elicited in the finger or wrist flexor muscles, and the patient's resting hand posture is flexed when the patient is standing with the upper arm pendant and the elbow flexed);
- Age 18 years or older;
- Stable pattern of pain-medication use for at least one month prior to enrollment;
- Medically stable;
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- Able to travel to the testing center;
- Mentally capable to understand and carry out the procedures and communicate concerns; and
- Able and willing to participate and provide informed consent.
- Ability to bring the wrist into neutral posture and the MCP joints into 30 degrees of flexion
Who cannot join
- Pregnant, nursing, or planning to become pregnant within the study timeframe;
- Presence of electronic implants (e.g., cardiac pacemaker, cochlear implant, neurostimulator, etc.);
- Presence of metallic implants, such as artificial elbow implants or metal screws, in the immediate field of the magnetic coil (on the arm between the fingers and the shoulder).
- Use of electrical stimulation for treatment of relevant extensor muscles in the past month;
- Inability to recruit muscles through surface electrical stimulation because of excessive adipose tissue;
- Presence of other unrelated hand or wrist pathologies; participating in other treatments including active physical therapy or drug therapy that affect their hand or wrist.
- Severe hemineglect; and
- Cancer or other serious illness, including a disease other than stroke resulting in motor dysfunction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rancho Los Angeles National Rehabilitation Center
Downey, California, 90242
About this study
Official title: BION Implantable Microstimulator
The study looks at a new treatment for wrist and finger contractures -- a condition where the affected hand is in a "closed" position, with the wrist and fingers stiff and difficult to move from that position. We want to study if stimulation of wrist and finger muscles using an implanted neuromuscular stimulator (BION) will be more or less effective than doing passive exercises of the affected hand to improve the range of movement at wrist and finger joints. Subjects of this study will be randomized into one of three groups: one doing passive movement therapy; one receiving surface stimulation (electrical stimulation with electrodes on the skin of the arm) and one doing BION® therapy. The passive movement group will do therapy for 12 weeks. Subjects in either stimulation group will receive stimulation for 6 weeks and then only passive therapy for 6 weeks.
Read the detailed description
BION™ Experimental Group
Following implantation, the patients receiving BIONs will have a 3 to 7 day healing period. During this period, subjects will not receive active therapy. At the end of this healing period, subjects will come to the testing center so that the examiner can program the exercise patterns. They will be instructed to increase the strength of their muscle contractions as tolerance permits. The goal for the BION™ patients is to achieve 30 minutes of stimulation twice daily, using a cycled stimulation at frequencies adequate to produce tetanic contraction, (typically 25-35 pps) that raises the joint through full range of motion against gravity (a range graded as 3/5) based on the available range of motion. The intensity, duration and frequency of the exercise program will be modified according to the progress of the participant, so that the strength of the contraction is increased over time.
Surface Stimulation Group
Patients will be instructed to stimulate twice daily for 30 minutes through surface electrodes placed according to instructions that the subject has been given. Stimulus parameters will be similar to those reported in earlier successful stimulation studies. The parameters should achieve a tetanic contraction that raises the joint through full range of motion against gravity (graded 3/5) based on the patient's available range of motion, and cycled, typically at 25-35 pps, using stimulus ramps as necessary so that contractions are smoothly graded and comfortable. Every effort will be made to ensure that the parameters needed in this group are chosen to produce a similar type of contraction to that obtained with BION™ stimulation.
Control Group with conservative therapy (Range of motion exercises)
The research participant is instructed in self-administered, standard range of motion stretching exercises. If the patient is unable to stretch the fingers into extension, a family member or a care-giver will be instructed to assist. They will be instructed to exercise the affected hand twice daily, repeating the exercise a minimum of 15 times in each session for 6 weeks. Control subjects will return to the clinic every two weeks for the first 6 weeks and every 3 weeks during the follow-up period. During these visits, passive range of motion testing will be administered.
- Conditions
- Hand Deformities
- Being tested
- BION stimulation
- Keywords
- Neuromuscular stimulator, Flexor deformities of wrist and fingers
- Medical subject headings
- Hand Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BION stimulationDevice
BION™ Experimental Group
The goal for the BION™ patients is to achieve 30 minutes of stimulation twice daily, using a cycled stimulation at frequencies adequate to produce tetanic contraction, (typically 25-35 pps) that raises the joint through full range of motion against gravity (a range graded as 3/5) based on the available range of motion.
Surface Stimulation Group
Patients will be instructed to stimulate twice daily for 30 minutes through surface electrodes placed according to instructions that the subject has been given. Every effort will be made to ensure that the parameters needed in this group are chosen to produce a similar type of contraction to that obtained with BION™ stimulation.
Control Group with conservative therapy (Range of motion exercises)
The research participant is instructed in self-administered, standard range of motion stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BION™ Experimental Group Receives: Device: BION stimulation |
| 2 | Active comparator | Surface Stimulation Group Receives: Device: BION stimulation |
| 3 | Active comparator | Control Group with conservative therapy (Range of motion exercises) Receives: Device: BION stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
passive Range of Motion, active Range of Motion, Rancho Arm Function Scale, Fugl Meyer Function Scale
Measured: baseline, 2 weeks, 4 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startApr 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand DeformitiesStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald E. Loeb, M.D., University of Southern California
- Investigators
- Lucinda Baker, M.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628537
- Sponsor's protocol ID
- BT4
- Status last verified
- Jun 2015
- First submitted
- 25 Feb 2008
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Loeb GE, Richmond FJ, Baker LL. The BION devices: injectable interfaces with peripheral nerves and muscles. Neurosurg Focus. 2006 May 15;20(5):E2. doi: 10.3171/foc.2006.20.5.3.
PubMed 16711659
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BION Implantable Microstimulator
- ClinicalTrials.gov ID
- NCT00628537
- Acronym / sponsor ID
- BT4
- Conditions
- Hand Deformities
- Keywords
- Neuromuscular stimulator, Flexor deformities of wrist and fingers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Mar 2008 (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 study looks at a new treatment for wrist and finger contractures -- a condition where the affected hand is in a "closed" position, with the wrist and fingers stiff and difficult to move from that position. We want to study if stimulation of wrist and finger muscles using an implanted neuromuscular stimulator (BION) will be more or less effective than doing passive exercises of the affected hand to improve the range of movement at wrist and finger joints. Subjects of this study will be randomized into one of three groups: one doing passive movement therapy; one receiving surface stimulation (electrical stimulation with electrodes on the skin of the arm) and one doing BION® therapy. The passive movement group will do therapy for 12 weeks. Subjects in either stimulation group will receive stimulation for 6 weeks and then only passive therapy for 6 weeks.
Detailed description
BION™ Experimental Group
Following implantation, the patients receiving BIONs will have a 3 to 7 day healing period. During this period, subjects will not receive active therapy. At the end of this healing period, subjects will come to the testing center so that the examiner can program the exercise patterns. They will be instructed to increase the strength of their muscle contractions as tolerance permits. The goal for the BION™ patients is to achieve 30 minutes of stimulation twice daily, using a cycled stimulation at frequencies adequate to produce tetanic contraction, (typically 25-35 pps) that raises the joint through full range of motion against gravity (a range graded as 3/5) based on the available range of motion. The intensity, duration and frequency of the exercise program will be modified according to the progress of the participant, so that the strength of the contraction is increased over time.
Surface Stimulation Group
Patients will be instructed to stimulate twice daily for 30 minutes through surface electrodes placed according to instructions that the subject has been given. Stimulus parameters will be similar to those reported in earlier successful stimulation studies. The parameters should achieve a tetanic contraction that raises the joint through full range of motion against gravity (graded 3/5) based on the patient's available range of motion, and cycled, typically at 25-35 pps, using stimulus ramps as necessary so that contractions are smoothly graded and comfortable. Every effort will be made to ensure that the parameters needed in this group are chosen to produce a similar type of contraction to that obtained with BION™ stimulation.
Control Group with conservative therapy (Range of motion exercises)
The research participant is instructed in self-administered, standard range of motion stretching exercises. If the patient is unable to stretch the fingers into extension, a family member or a care-giver will be instructed to assist. They will be instructed to exercise the affected hand twice daily, repeating the exercise a minimum of 15 times in each session for 6 weeks. Control subjects will return to the clinic every two weeks for the first 6 weeks and every 3 weeks during the follow-up period. During these visits, passive range of motion testing will be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: BION stimulationBION™ Experimental Group |
| 2 | Active comparator | Device: BION stimulationSurface Stimulation Group |
| 3 | Active comparator | Device: BION stimulationControl Group with conservative therapy (Range of motion exercises) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of hemiplegic stroke 6 months to 20 years prior to enrollment in this study;
- Paresis of extensors in the forearm;
- Demonstrable restriction of hand or wrist mobility (i.e. significant stretch response, defined as a 2+ or greater on the Ashworth scale, can be elicited in the finger or wrist flexor muscles, and the patient's resting hand posture is flexed when the patient is standing with the upper arm pendant and the elbow flexed);
- Age 18 years or older;
- Stable pattern of pain-medication use for at least one month prior to enrollment;
Key exclusion criteria (8 listed)
- Pregnant, nursing, or planning to become pregnant within the study timeframe;
- Presence of electronic implants (e.g., cardiac pacemaker, cochlear implant, neurostimulator, etc.);
- Presence of metallic implants, such as artificial elbow implants or metal screws, in the immediate field of the magnetic coil (on the arm between the fingers and the shoulder).
- Use of electrical stimulation for treatment of relevant extensor muscles in the past month;
- Inability to recruit muscles through surface electrical stimulation because of excessive adipose tissue;
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 |
|---|---|---|
| BION stimulationBION™ Experimental Group The goal for the BION™ patients is to achieve 30 minutes of stimulation twice daily, using a cycled stimulation at frequencies adequate to produce tetanic contraction, (typically 25-35 pps) that raises the joint through full range of motion against gravity (a range graded as 3/5) based on the available range of motion. Surface Stimulation Group Patients will be instructed to stimulate twice daily for 30 minutes through surface electrodes placed according to instructions that the subject has been given. Every effort will be made to ensure that the parameters needed in this group are chosen to produce a similar type of contraction to that obtained with BION™ stimulation. Control Group with conservative therapy (Range of motion exercises) The research participant is instructed in self-administered, standard range of motion stretching exercises. | Device | 1, 2, 3 |
Primary outcome
passive Range of Motion, active Range of Motion, Rancho Arm Function Scale, Fugl Meyer Function Scale
Time frame: baseline, 2 weeks, 4 weeks and 6 weeks
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 3 Jun 2015.
- Results publication: PubMed 16711659Loeb GE, Richmond FJ, Baker LL. The BION devices: injectable interfaces with peripheral nerves and muscles. Neurosurg Focus. 2006 May 15;20(5):E2. doi: 10.3171/foc.2006.20.5.3.
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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.
Lucinda Baker, M.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BION stimulation in people with Hand Deformities, run by University of Southern California at 1 site in United States.
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 10 inclusion and 8 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 3 Jun 2015. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
passive Range of Motion, active Range of Motion, Rancho Arm Function Scale, Fugl Meyer Function Scale (time frame: baseline, 2 weeks, 4 weeks and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628537, which also lists 1 linked publication.
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 3 Jun 2015.