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

NCT01963832 | Withdrawn Phase 2 DMC

• 1 other identifier: F130410007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Stroke With Affected Arm Motor Function

Keywords

stroke; Fluoxetine (FLX); eCIMT; Central Nervous System

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to 90 days

Secondary Outcomes (2)

• Grade 4/5 MAL Arm Use scale

  baseline to 12 months after therapy

• Grade 4/5 Wolf Motor Function Test Performance Rate score

  baseline to 90 days

Study Arms (4)

eCMIT and Fluoxetine

EXPERIMENTAL

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

Drug: Fluoxetine; Procedure: eCMIT

eCIMT and placebo

EXPERIMENTAL

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

Drug: Fluoxetine; Drug: Placebo

Usual care and fluoxetine

EXPERIMENTAL

Ususal physical care combined with Fluoxetine (FLX)

Drug: Fluoxetine; Procedure: Usual Care

Usual care and placebo

EXPERIMENTAL

Usual physical care combined with placebo

Drug: Placebo; Procedure: Usual Care

Interventions

Fluoxetine DRUG

Usual care and fluoxetine; eCIMT and placebo; eCMIT and Fluoxetine

Placebo DRUG

Usual care and placebo; eCIMT and placebo

eCMIT PROCEDURE

eCMIT and Fluoxetine

Usual Care PROCEDURE

Usual care and fluoxetine; Usual care and placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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.
• 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,

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 16, 2013
• Study Start: November 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: January 12, 2015

Record last verified: 2014-12

Locations

US (1)