StrokePhase 1NCT01575366
Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke
A Phase 1 study testing Tracking training in people with Stroke, run by University of Minnesota at 1 site in United States.
Trial summary
Aim 1. Determine whether higher-velocity finger tracking training improves hand function more than slower velocity training. Working hypotheses: The higher-velocity training will have significantly greater functional improvement compared to the lower-velocity training, as measured by standardized upper extremity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Tracking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke - due to higher risk of seizures in hemorrhagic stroke
- Subcortical location of stroke
- Stroke after 6 months - lower limit of 6 months to avoid confounding from spontaneous recovery (Jorgensen, Nakayama et al. 1995) and no upper limit to maximize pool of candidate subjects while still showing training effect (Carey, Kimberley et al. 2002)
- At least 18 years of age - to maximize pool of candidate subjects
- Mini-Mental State Examination score >24 - to ensure satisfactory cognition to perform tasks
- Satisfactory corrected vision - to see computer screen during training and testing
Show all 10Show fewer
- Active range of MP joint at paretic index finger of at least 10 degrees - based on minimal movement required to perform training task successfully, and that larger amplitudes would reduce the pool of subjects available for participating in the study.
- Ability to pronate the forearm so that index finger extension movement during training is vertically upward and relaxation results in the finger falling back to the flexed starting position
- not currently receiving any other therapy - to avoid confounding treatment effects
- Approval for participation by a neurologist - to ensure subject is reasonably safe to receive TMS testing. Subjects with proprioceptive loss or expressive aphasia will be included, providing they can carryout the training task.
Who cannot join
- Inability to follow 3-step commands
- A visual field cut that causes subjects not to see all indicators on a computer screen positioned centrally in from of them
- History of seizures
- Family member with history of seizures
- Presence of any other neuromuscular disorders
- Pregnancy
Show all 11Show fewer
- Claustrophobia
- Indwelling metal or medical devices/implants incompatible with functional fMRI testing
- History of exposure to finger tracking training.
- Informed consent will be obtained and TMS/fMRI safety screenings will be conducted prior to testing procedures.
- Subjects will be recruited as volunteers from letters sent to previous research subjects inviting their participation, through visits to local stroke support groups meetings, newspaper advertisements and referrals from neurologists.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Aim 1. Determine whether higher-velocity finger tracking training improves hand function more than slower velocity training. Working hypotheses: The higher-velocity training will have significantly greater functional improvement compared to the lower-velocity training, as measured by standardized upper extremity functional tests (Jebsen Taylor test, Box \& Block Test, and Finger extension force test)
Aim 2. Ascertain whether higher-velocity finger tracking training differentially induces cortical reorganization as compared to lower-velocity finger tracking training.
Read more
Working hypotheses: The higher-velocity training will have significantly greater cortical reorganization compared to the lower-velocity training, as measured by:
- TMS - increased amplitude of motor evoked potentials (MEP) from paretic extensor digitorum muscle in response to paired-pulse TMS to ipsilesional primary motor area (M1).
- fMRI - increased volume of activation, signal intensity, and laterality of ipsilesional M1.
Aim 3. Explore whether the functional improvements correlate with the cortical reorganization. Working hypotheses: The functional improvements will correlate with the cortical reorganization.
- Conditions
- Stroke
- Being tested
- Tracking training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracking trainingBehavioural
The paretic finger movement training at different velocities included two 5-week periods of five days per week, 2-hours per day phases. The frequency for the higher-velocity training is 0.8 Hz, whereas the lower frequency training is 4 times slower, at 0.2 Hz. The two periods are each followed by a 3-week baseline period. The subject is seated in front of a laptop computer with the paretic forearm resting on the arm of the chair in a quiet room at home. The position of the forearm is pronated. An electrogoniometer, composed of a potentiometer attached to a custom hand splint, is placed on the paretic index finger with the potentiometer centered at the metacarpophalangeal joint. To keep the training session time equal between the two training phases, the duration of each slow training trial is 5 sec, compared to 20 sec for each fast training trial. Ultimately, the total number of required finger extension/flexion training movements is equal between the two phases.
| Study group | Role | What they receive |
|---|---|---|
| Slow tracking training | Experimental | Not described Receives: Behavioral: Tracking training |
| Fast tracking training | Experimental | Not described Receives: Behavioral: Tracking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand function improvement
Jebsen Taylor test, Box \& Block Test, and Finger extension force test
Measured: taken at weekly intervals for the whole study length, 20 weeks.
Secondary outcomes (2)
corticospinal excitability
TMS
Measured: taken at weekly intervals for the whole study length, 20 weeks.
cognitive function
Measured: at the beginning and at the end of the study, which are 1st and 20th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startFeb 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huiqiong Deng, MD, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575366
- Sponsor's protocol ID
- 0912M74993
- Status last verified
- Oct 2019
- First submitted
- 19 Mar 2012
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke
- ClinicalTrials.gov ID
- NCT01575366
- Acronym / sponsor ID
- 0912M74993
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Apr 2012 (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.
Aim 1. Determine whether higher-velocity finger tracking training improves hand function more than slower velocity training. Working hypotheses: The higher-velocity training will have significantly greater functional improvement compared to the lower-velocity training, as measured by standardized upper extremity functional tests (Jebsen Taylor test, Box \& Block Test, and Finger extension force test)
Aim 2. Ascertain whether higher-velocity finger tracking training differentially induces cortical reorganization as compared to lower-velocity finger tracking training.
Working hypotheses: The higher-velocity training will have significantly greater cortical reorganization compared to the lower-velocity training, as measured by:
- TMS - increased amplitude of motor evoked potentials (MEP) from paretic extensor digitorum muscle in response to paired-pulse TMS to ipsilesional primary motor area (M1).
- fMRI - increased volume of activation, signal intensity, and laterality of ipsilesional M1.
Aim 3. Explore whether the functional improvements correlate with the cortical reorganization. Working hypotheses: The functional improvements will correlate with the cortical reorganization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow tracking training | Experimental | Behavioral: Tracking training |
| Fast tracking training | Experimental | Behavioral: Tracking training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ischemic stroke - due to higher risk of seizures in hemorrhagic stroke
- Subcortical location of stroke
- Stroke after 6 months - lower limit of 6 months to avoid confounding from spontaneous recovery (Jorgensen, Nakayama et al. 1995) and no upper limit to maximize pool of candidate subjects while still showing training effect (Carey, Kimberley et al. 2002)
- At least 18 years of age - to maximize pool of candidate subjects
- Mini-Mental State Examination score >24 - to ensure satisfactory cognition to perform tasks
Key exclusion criteria (11 listed)
- Inability to follow 3-step commands
- A visual field cut that causes subjects not to see all indicators on a computer screen positioned centrally in from of them
- History of seizures
- Family member with history of seizures
- Presence of any other neuromuscular disorders
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 |
|---|---|---|
| Tracking trainingThe paretic finger movement training at different velocities included two 5-week periods of five days per week, 2-hours per day phases. The frequency for the higher-velocity training is 0.8 Hz, whereas the lower frequency training is 4 times slower, at 0.2 Hz. The two periods are each followed by a 3-week baseline period. The subject is seated in front of a laptop computer with the paretic forearm resting on the arm of the chair in a quiet room at home. The position of the forearm is pronated. An electrogoniometer, composed of a potentiometer attached to a custom hand splint, is placed on the paretic index finger with the potentiometer centered at the metacarpophalangeal joint. To keep the training session time equal between the two training phases, the duration of each slow training trial is 5 sec, compared to 20 sec for each fast training trial. Ultimately, the total number of required finger extension/flexion training movements is equal between the two phases. | Behavioural | Fast tracking training, Slow tracking training |
Primary outcome
Hand function improvement
Time frame: taken at weekly intervals for the whole study length, 20 weeks.
Jebsen Taylor test, Box \& Block Test, and Finger extension force test
2 secondary outcomes
corticospinal excitability
Time frame: taken at weekly intervals for the whole study length, 20 weeks.
cognitive function
Time frame: at the beginning and at the end of the study, which are 1st and 20th week.
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 1 Nov 2019.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Huiqiong Deng, MD, MS principal investigator
University of Minnesota
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 Tracking training in people with Stroke, run by University of Minnesota 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 11 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 1 Nov 2019. 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?
Hand function improvement (time frame: taken at weekly intervals for the whole study length, 20 weeks.). 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 1 Nov 2019.