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RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke

Primary Purpose

Severe Stroke With Affected Arm Motor Function

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Placebo
eCMIT
Usual Care
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Stroke With Affected Arm Motor Function focused on measuring stroke, Fluoxetine (FLX), eCIMT, Central Nervous System

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

eCMIT and Fluoxetine

eCIMT and placebo

Usual care and fluoxetine

Usual care and placebo

Arm Description

expanded form of Constraint Induced Movement Therapy (eCIMT) combined with Fluoxetine (FLX)

expanded form of Constraint Induced Movement Therapy (eCIMT) combined with placebo

Ususal physical care combined with Fluoxetine (FLX)

Usual physical care combined with placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Grade 4/5 MAL Arm Use scale
See primary outcome.
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.

Full Information

First Posted
October 11, 2013
Last Updated
January 9, 2015
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01963832
Brief Title
RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke
Official Title
RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
not funded
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Stroke With Affected Arm Motor Function
Keywords
stroke, Fluoxetine (FLX), eCIMT, Central Nervous System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eCMIT and Fluoxetine
Arm Type
Experimental
Arm Description
expanded form of Constraint Induced Movement Therapy (eCIMT) combined with Fluoxetine (FLX)
Arm Title
eCIMT and placebo
Arm Type
Experimental
Arm Description
expanded form of Constraint Induced Movement Therapy (eCIMT) combined with placebo
Arm Title
Usual care and fluoxetine
Arm Type
Experimental
Arm Description
Ususal physical care combined with Fluoxetine (FLX)
Arm Title
Usual care and placebo
Arm Type
Experimental
Arm Description
Usual physical care combined with placebo
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Procedure
Intervention Name(s)
eCMIT
Intervention Type
Procedure
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Grade 4/5 Motor Activity Log (MAL) Arm Use Scale
Description
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.
Time Frame
baseline to 90 days
Secondary Outcome Measure Information:
Title
Grade 4/5 MAL Arm Use scale
Description
See primary outcome.
Time Frame
baseline to 12 months after therapy
Title
Grade 4/5 Wolf Motor Function Test Performance Rate score
Description
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.
Time Frame
baseline to 90 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

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RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke

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