Severe Stroke With Affected Arm Motor FunctionPhase 2NCT01963832
RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke
A Phase 2 study testing Fluoxetine and eCMIT in people with Severe Stroke With Affected Arm Motor Function, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Stroke patients who have little or no voluntary movement in the hand on the more affected side of their body more than one year after stroke have few treatment options. This project proposes to test the efficacy of a form of Constraint-Induced Movement therapy designed for patients with such severe impairment in… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Severe Stroke With Affected Arm Motor Function
- What is being tested?
- Fluoxetine and eCMIT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Nov 2021
- Phase
- Phase 2
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Motor criteria determinations will be made with the subject sitting. The more-affected forearm will be resting on a supporting surface (e.g., arm of a chair) to allow for maximum wrist flexion with gravity.
- The minimum motor criterion (MMC) for inclusion in Grade 5 (severe impairment) will be ability to:
- initiate extension against gravity at the wrist or at least one digit,
- initiate extension and flexion at the elbow,
- actively move the shoulder ≥ 30° in flexion, abduction, or scaption
- The MMC for inclusion in Grade 4 (moderately severe impairment) will be ability to actively:
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- extend at least two fingers more than 0° but less than < 10°,
- extend or abduct thumb ≥ 10°
- extend wrist ≥ 10° from a fully flexed starting position,
- extend elbow ≥ 20° from a 90° flexed starting position,
- flex and abduct shoulder > 45°.
- Stroke patients who can extend at least two fingers ≥ 10° at the metacarpophalangeal (MCP) joint and either the proximal or distal interphalangeal (PIP or DIP) joint will be excluded.
- Additional inclusion criteria are:
- must score ≤ 4 on the Modified Ashworth Scale (23)116 for all more-affected arm joints
- meet the following passive range of movement criteria:
- ≥ 90° shoulder flexion,
- ≥ 90° shoulder abduction,
- ≥ 45° shoulder external rotation,
- ≤ 30° short of normal elbow extension, forearm supination to at least neutral,
- forearm pronation 45° or more from neutral,
- ≤ 35° short of normal wrist extension,
- ≤ 35° short of normal MCP extension on all the digits.
Who cannot join
- Less than 1 year post-stroke.
- Frailty or insufficient stamina to carry out the requirements of the therapy (based on clinical judgment).
- Ferrous metal in body or medical complications or psychological problems that would prohibit receiving an MRI.
- Positive pregnancy test for women of child-bearing age since 3T MRI is contraindicated for pregnant women.
- Other neurological or musculoskeletal conditions affecting UE function.
- Medication will not be exclusionary except in the following cases: a. participation in any experimental drug study, b. Botox injections to the more-affected UE < 3 months prior to enrollment, c. Baclofen or Dantrium taken orally at the time of study, d. fluoxetine or other antidepressant with SSRI-like properties taken < 3 months prior to enrollment, e. any agents that would contraindicate concurrent fluoxetine. If subjects are on other medications, the medications will be recorded and the possible effect on treatment outcome will be analyzed separately.
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- Moderate or greater depressive symptoms as indicated by a score > 30/63 on the Beck Depression Inventory (24,25).117, 118
- Concurrent participation in any formal physical rehabilitation program or clinical trial.
- Excessive pain in any joint of the more-affected arm that could limit ability to cooperate with the intervention (based on clinical judgment).
- Serious cognitive deficits manifested by a Folstein Mini-Mental State Examination (MMSE) score ≤ 24 (26).119
- Inadequate ability to follow test instructions as indicated by a Token Test of the Multilingual Aphasia Examination score ≤ 36 (27).120
- Serious, uncontrolled medical problems as judged by the Medical Director (e.g., severe rheumatoid arthritis, serious joint deformity of arthritic origin, symptomatic cancer or renal disease, any end-stage pulmonary or cardiovascular disease, senility or a deteriorated condition due to age, uncontrolled epilepsy).
- Motor problems that are not primarily unilateral.
- Poor motivation to participate in the study (if a person is only marginally interested, he/she is a bad risk as a subject).
- Less than 40 years old.
- Previous CIMT.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Stroke patients who have little or no voluntary movement in the hand on the more affected side of their body more than one year after stroke have few treatment options. This project proposes to test the efficacy of a form of Constraint-Induced Movement therapy designed for patients with such severe impairment in conjunction with an agent, fluoxetine, which has been shown in some studies to enhance brain neuroplasticity in response to training. Constraint-Induced Movement therapy, which is abbreviated CIMT, is a form of physical rehabilitation based on basic research in neuroscience and behavioral science. If the project is successful, an efficacious, evidence-based therapy will become available to stroke patients for what is now a largely untreated condition
- Being tested
- Fluoxetine, Placebo, eCMIT, Usual Care
- Keywords
- stroke, Fluoxetine (FLX), eCIMT, Central Nervous System
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
PlaceboDrug
eCMITProcedure or surgery
Usual CareProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| eCMIT and Fluoxetine | Experimental | expanded form of Constraint Induced Movement Therapy (eCIMT) combined with Fluoxetine (FLX) Receives: Drug: Fluoxetine; Procedure: eCMIT |
| eCIMT and placebo | Experimental | expanded form of Constraint Induced Movement Therapy (eCIMT) combined with placebo Receives: Drug: Fluoxetine; Drug: Placebo |
| Usual care and fluoxetine | Experimental | Ususal physical care combined with Fluoxetine (FLX) Receives: Drug: Fluoxetine; Procedure: Usual Care |
| Usual care and placebo | Experimental | Usual physical care combined with placebo Receives: Drug: Placebo; Procedure: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 4/5 Motor Activity Log (MAL) Arm Use Scale
This is a structured interview. Patients and family caregivers, if available, are asked to rate how well and how much the stroke survivor has used his or her more-affected arm on 30 upper-extremity tasks outside of the treatment setting over a specified period. The test score is the mean of the item scores. The primary outcome will be change on this instrument from pre- to post-treatment.
Measured: baseline to 90 days
Secondary outcomes (2)
Grade 4/5 MAL Arm Use scale
See primary outcome.
Measured: baseline to 12 months after therapy
Grade 4/5 Wolf Motor Function Test Performance Rate score
This is a laboratory motor performance test. Patients are asked to complete the items are rapidly as possible. Performance is timed and converted to a rate (repetitions/60 s). The test score is the mean of the item scores.
Measured: baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startNov 2016
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Stroke With Affected Arm Motor FunctionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963832
- Sponsor's protocol ID
- F130410007
- Status last verified
- Dec 2014
- First submitted
- 11 Oct 2013
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke
- ClinicalTrials.gov ID
- NCT01963832
- Acronym / sponsor ID
- F130410007
- Keywords
- stroke, Fluoxetine (FLX), eCIMT, Central Nervous System
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 16 Oct 2013 (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.
Stroke patients who have little or no voluntary movement in the hand on the more affected side of their body more than one year after stroke have few treatment options. This project proposes to test the efficacy of a form of Constraint-Induced Movement therapy designed for patients with such severe impairment in conjunction with an agent, fluoxetine, which has been shown in some studies to enhance brain neuroplasticity in response to training. Constraint-Induced Movement therapy, which is abbreviated CIMT, is a form of physical rehabilitation based on basic research in neuroscience and behavioral science. If the project is successful, an efficacious, evidence-based therapy will become available to stroke patients for what is now a largely untreated condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| eCMIT and Fluoxetine | Experimental | Drug: Fluoxetine, Procedure: eCMITexpanded form of Constraint Induced Movement Therapy (eCIMT) combined with Fluoxetine (FLX) |
| eCIMT and placebo | Experimental | Drug: Fluoxetine, Drug: Placeboexpanded form of Constraint Induced Movement Therapy (eCIMT) combined with placebo |
| Usual care and fluoxetine | Experimental | Drug: Fluoxetine, Procedure: Usual CareUsusal physical care combined with Fluoxetine (FLX) |
| Usual care and placebo | Experimental | Drug: Placebo, Procedure: Usual CareUsual physical care combined with placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Motor criteria determinations will be made with the subject sitting. The more-affected forearm will be resting on a supporting surface (e.g., arm of a chair) to allow for maximum wrist flexion with gravity.
- The minimum motor criterion (MMC) for inclusion in Grade 5 (severe impairment) will be ability to:
- The MMC for inclusion in Grade 4 (moderately severe impairment) will be ability to actively:
- Stroke patients who can extend at least two fingers ≥ 10° at the metacarpophalangeal (MCP) joint and either the proximal or distal interphalangeal (PIP or DIP) joint will be excluded.
- Additional inclusion criteria are:
Key exclusion criteria (16 listed)
- Less than 1 year post-stroke.
- Frailty or insufficient stamina to carry out the requirements of the therapy (based on clinical judgment).
- Ferrous metal in body or medical complications or psychological problems that would prohibit receiving an MRI.
- Positive pregnancy test for women of child-bearing age since 3T MRI is contraindicated for pregnant women.
- Other neurological or musculoskeletal conditions affecting UE function.
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 |
|---|---|---|
| Fluoxetine | Drug | Usual care and fluoxetine, eCIMT and placebo, eCMIT and Fluoxetine |
| Placebo | Drug | Usual care and placebo, eCIMT and placebo |
| eCMIT | Procedure or surgery | eCMIT and Fluoxetine |
| Usual Care | Procedure or surgery | Usual care and fluoxetine, Usual care and placebo |
Primary outcome
Grade 4/5 Motor Activity Log (MAL) Arm Use Scale
Time frame: baseline to 90 days
This is a structured interview. Patients and family caregivers, if available, are asked to rate how well and how much the stroke survivor has used his or her more-affected arm on 30 upper-extremity tasks outside of the treatment setting over a specified period. The test score is the mean of the item scores. The primary outcome will be change on this instrument from pre- to post-treatment.
2 secondary outcomes
Grade 4/5 MAL Arm Use scale
Time frame: baseline to 12 months after therapy
Grade 4/5 Wolf Motor Function Test Performance Rate score
Time frame: baseline to 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoxetine and eCMIT in people with Severe Stroke With Affected Arm Motor Function, run by University of Alabama at Birmingham 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 22 inclusion and 16 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: withdrawn, as of the sponsor's last update on 12 Jan 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Grade 4/5 Motor Activity Log (MAL) Arm Use Scale (time frame: baseline to 90 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 Jan 2015.