Hand TransplantationNCT03610763
Harnessing Neuroplasticity to Enhance Functional Recovery During Chronic Recovery From Upper Extremity Nerve Repair
A study testing Transcranial Direct Current Stimulation and Modified Constraint Induced Movement Therapy in people with Hand Transplantation and Peripheral Nerve Injuries, run by University of Missouri-Columbia at 3 sites in United States.
Trial summary
This study adopts a strategy that has arisen from basic neuroscience research on facilitating adaptive brain plasticity and applies this to rehabilitation to improve functional recovery in peripheral nervous system injuries (including hand transplantation, hand replantation, and surgically repaired upper extremity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Transplantation, Peripheral Nerve Injuries, Neurologic Rehabilitation
- What is being tested?
- Transcranial Direct Current Stimulation and Modified Constraint Induced Movement Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Aug 2018to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals whom have received a unilateral allogeneic transplantation proximal to the wrist and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
- Individuals whom have undergone a complete amputation the hand between the wrist and elbow followed by successful re-attachment and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
- Individuals whom have undergone repairs of the median, ulnar, or other related or nearby nerve(s) following complex volar forearm lacerations or other injuries between the distal wrist crease and the flexor musculotendinous junctions. Individuals must be at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
Who cannot join
- Individuals with significant/severe brain trauma
- Serious psychiatric conditions
- Chronic or severe neurological conditions.
- Current pregnancy
- History of seizures or unexplained loss of consciousness
- Metallic implants above the chest
- Certain implanted medical devices.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65211
Scott H Frey, Ph.D., Ed.M., 573-882-4572, freylab@missouri.edu
- Recruiting
Christine Kleinert Institute for Hand & Microsurgery
Louisville, Kentucky, 40202
Christina Kaufman, Ph.D., 502-562-0390, ckaufman@cmki.org
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Amy Moore, MD, 314-454-4894, mooream@wustl.edu
About this study
Official title: Harnessing Neuroplasticity to Enhance Functional Recovery in Allogeneic Hand Transplant and Heterotopic Hand Replant Recipients
This study adopts a strategy that has arisen from basic neuroscience research on facilitating adaptive brain plasticity and applies this to rehabilitation to improve functional recovery in peripheral nervous system injuries (including hand transplantation, hand replantation, and surgically repaired upper extremity nerve injuries). The technique involves combining behavioral training with transcranial direct current stimulation (tDCS)-a non-invasive form of brain stimulation capable of facilitating adaptive changes in brain organization.
Read the detailed description
This study will implement and evaluate an innovative program of post hand transplant rehabilitation; one that harnesses recent discoveries in neuroscience to facilitate long-term, experience-dependent adaptations within the brain's sensory and motor systems. The current approach to rehabilitation of function in allogeneic hand transplant recipients is largely the same as standard-of-care following hand replantation (re-attachment) and peripheral nerve repairs. This involves an eclectic combination of traditional therapies. In seeking to improve on this approach, there is potentially much to be gained by considering evidence that limb amputation not only impacts the peripheral nervous system but also the brain, and tailoring interventions accordingly.
- Being tested
- Transcranial Direct Current Stimulation, Modified Constraint Induced Movement Therapy
- Keywords
- Rehabilitation Neuroscience, Transcranial Direct Current Stimulation, Rehabilitation Therapy, Neuroplasticity, Transplantation, Hand Therapy, Constraint Induced Movement Therapy, Peripheral Nerve Injuries, tDCS, CIMT
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
Transcranial direct current stimulation (tDCS) is a portable neurostimulation method that modulates cortical excitability. The technique involves placing two saline-soaked electrodes (anode and cathode) on the scalp and passing a small direct current (1.5 milliamps; mA) between them. Cortex underlying the anode is more easily excited due to lowered thresholds for depolarization of glutamatergic neurons, while thresholds are increased in neurons beneath the cathode, making them less excitable. Sham stimulation is easily implemented, and the technique can be effectively double-blinded.
Modified Constraint Induced Movement TherapyBehavioural
Also called CIMT
In CIMT, patients are required to wear a mitt that restricts use of the unaffected limb while they practice structured tasks and also engage in activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Transplantation/Replantation Patients | Active comparator | Can plateaued hand function in hand transplantation patients/hand replantation patients in the chronic stage of recovery be facilitated by use of bi-hemispheric transcranial direct current stimulation (tDCS) combined with modified Constraint Induced Movement Therapy (CIMT)? Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Modified Constraint Induced Movement Therapy |
| Nerve Injury Patients active | Active comparator | Can plateaued hand function in peripheral nervous system injuries in the chronic stage of recovery be facilitated by use of bi-hemispheric transcranial direct current stimulation (tDCS) combined with modified Constraint Induced Movement Therapy (CIMT)? Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Modified Constraint Induced Movement Therapy |
| Actigraphy Testing | No intervention | We will acquire a set of actigraphy data from a group of hand transplant/replant patients and unilateral, adult amputees in order to evaluate typical patterns of limb use prior to hand transplantation and to investigate prosthesis utilization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks.
This functional test measures quality of sensibility of the hand. This outcome measure will investigate any change in participant performance between pre- and post-intervention sessions of the Dellon Modified Moberg Pick-Up Test.
Measured: Baseline, immediately after end of intervention (+/- 3 days).
Secondary outcomes (2)
Change from Baseline Action Research Arm Test (ARAT) performance at two weeks.
The Action Research Arm Test (ARAT) measures limb function by having participants pick up various objects of different sizes, different weights, and different shapes (e.g., a glass of water, a cricket ball). This secondary outcome measure will investigate any change in participant performance between pre- and post-intervention sessions of the ARAT.
Measured: Baseline, immediately after end of intervention (+/- 3 days).
Change from baseline upper limb movement as measured by actigraphy-derived variables during everyday life at periodic intervals after intervention.
This secondary outcome measure will employ actigraphy on participants to measure limb movement in everyday life before and after the intervention. Participants will wear wrist-watch like devices that contain accelerometers on each upper extremity in 24-72 hour sessions. Two primary variables will quantify upper limb activity from accelerometer data: the Bilateral Magnitude and the Magnitude Ratio. The Bilateral Magnitude quantifies the intensity of activity across both limbs, whereas the Magnitude Ratio quantifies the contribution of each limb to activity.
This outcome measure will investigate the change in the Bilateral Magnitude and Magnitude Ratio between a baseline pre-intervention test and post-intervention actigraphy sessions performed within one week of completion of the intervention, at 1 month post-intervention, 3-months post intervention, and 6-months post intervention.
Measured: Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start15 Aug 2018
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand TransplantationStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Christine M. Kleinert Institute for Hand and Microsurgery
- Responsible party
- Principal investigator, Scott H Frey, PhD, University of Missouri-Columbia
- Investigators
- Scott H Frey, Ph.D., Ed.M., Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610763
- Sponsor's protocol ID
- 2008784
- Other IDs
- CDMRP-MR141043
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2018
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Neuroplasticity to Enhance Functional Recovery in Allogeneic Hand Transplant and Heterotopic Hand Replant Recipients
- ClinicalTrials.gov ID
- NCT03610763
- Acronym / sponsor ID
- 2008784
- Keywords
- Rehabilitation Neuroscience, Transcranial Direct Current Stimulation, Rehabilitation Therapy, Neuroplasticity, Transplantation, Hand Therapy, Constraint Induced Movement Therapy, Peripheral Nerve Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, Christine M. Kleinert Institute for Hand and Microsurgery
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 1 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.
This study adopts a strategy that has arisen from basic neuroscience research on facilitating adaptive brain plasticity and applies this to rehabilitation to improve functional recovery in peripheral nervous system injuries (including hand transplantation, hand replantation, and surgically repaired upper extremity nerve injuries). The technique involves combining behavioral training with transcranial direct current stimulation (tDCS)-a non-invasive form of brain stimulation capable of facilitating adaptive changes in brain organization.
Detailed description
This study will implement and evaluate an innovative program of post hand transplant rehabilitation; one that harnesses recent discoveries in neuroscience to facilitate long-term, experience-dependent adaptations within the brain's sensory and motor systems. The current approach to rehabilitation of function in allogeneic hand transplant recipients is largely the same as standard-of-care following hand replantation (re-attachment) and peripheral nerve repairs. This involves an eclectic combination of traditional therapies. In seeking to improve on this approach, there is potentially much to be gained by considering evidence that limb amputation not only impacts the peripheral nervous system but also the brain, and tailoring interventions accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transplantation/Replantation Patients | Active comparator | Device: Transcranial Direct Current Stimulation, Behavioral: Modified Constraint Induced Movement TherapyCan plateaued hand function in hand transplantation patients/hand replantation patients in the chronic stage of recovery be facilitated by use of bi-hemispheric transcranial direct current stimulation (tDCS) combined with modified Constraint Induced Movement Therapy (CIMT)? |
| Nerve Injury Patients active | Active comparator | Device: Transcranial Direct Current Stimulation, Behavioral: Modified Constraint Induced Movement TherapyCan plateaued hand function in peripheral nervous system injuries in the chronic stage of recovery be facilitated by use of bi-hemispheric transcranial direct current stimulation (tDCS) combined with modified Constraint Induced Movement Therapy (CIMT)? |
| Actigraphy Testing | No intervention | –We will acquire a set of actigraphy data from a group of hand transplant/replant patients and unilateral, adult amputees in order to evaluate typical patterns of limb use prior to hand transplantation and to investigate prosthesis utilization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals whom have received a unilateral allogeneic transplantation proximal to the wrist and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
- Individuals whom have undergone a complete amputation the hand between the wrist and elbow followed by successful re-attachment and are at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
- Individuals whom have undergone repairs of the median, ulnar, or other related or nearby nerve(s) following complex volar forearm lacerations or other injuries between the distal wrist crease and the flexor musculotendinous junctions. Individuals must be at the chronic stage of recovery (approx. 12 - 18 months following surgery, when Tinel's sign reaches the distal fingertips).
Key exclusion criteria (7 listed)
- Individuals with significant/severe brain trauma
- Serious psychiatric conditions
- Chronic or severe neurological conditions.
- Current pregnancy
- History of seizures or unexplained loss of consciousness
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 |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSTranscranial direct current stimulation (tDCS) is a portable neurostimulation method that modulates cortical excitability. The technique involves placing two saline-soaked electrodes (anode and cathode) on the scalp and passing a small direct current (1.5 milliamps; mA) between them. Cortex underlying the anode is more easily excited due to lowered thresholds for depolarization of glutamatergic neurons, while thresholds are increased in neurons beneath the cathode, making them less excitable. Sham stimulation is easily implemented, and the technique can be effectively double-blinded. | Device | Nerve Injury Patients active, Transplantation/Replantation Patients |
| Modified Constraint Induced Movement TherapyAlso: CIMTIn CIMT, patients are required to wear a mitt that restricts use of the unaffected limb while they practice structured tasks and also engage in activities of daily living. | Behavioural | Nerve Injury Patients active, Transplantation/Replantation Patients |
Primary outcome
Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks.
Time frame: Baseline, immediately after end of intervention (+/- 3 days).
This functional test measures quality of sensibility of the hand. This outcome measure will investigate any change in participant performance between pre- and post-intervention sessions of the Dellon Modified Moberg Pick-Up Test.
2 secondary outcomes
Change from Baseline Action Research Arm Test (ARAT) performance at two weeks.
Time frame: Baseline, immediately after end of intervention (+/- 3 days).
Change from baseline upper limb movement as measured by actigraphy-derived variables during everyday life at periodic intervals after intervention.
Time frame: Baseline, post intervention at week 1, post intervention at 1 month, post intervention at 3 months, post intervention at 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Upper Extremity Vascularized Composite Allotransplantation: A Study Evaluating Safety, Functional Outcomes, and Patient-Reported Psychosocial Outcomes
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RecruitingPhase 2
Human Upper Extremity Allotransplantation
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Human Upper Extremity Allotransplantation: F/U Protocol
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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.
Scott H Frey, Ph.D., Ed.M. principal investigator
University of Missouri-Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation and Modified Constraint Induced Movement Therapy in people with Hand Transplantation and Peripheral Nerve Injuries, run by University of Missouri-Columbia at 3 sites 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott H Frey, Ph.D., Ed.M. (573-882-4572, freylab@missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Dellon Modified Moberg Pick-Up Test performance at two weeks. (time frame: Baseline, immediately after end of intervention (+/- 3 days).). 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 12 Jun 2024.