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Altering Activation Patterns Post-stroke

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ClinicalTrials.gov Identifier: NCT02418949
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : January 17, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Elliot Roth, Shirley Ryan AbilityLab

Brief Summary:
This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase of recovery in which the combination of drug therapy (cyproheptadine) and active movement practice (AMP) is used to encourage increased voluntary muscle control and strength.

Condition or disease Intervention/treatment Phase
Stroke Muscle Spasticity Hemiparesis Drug: Cyproheptadine Drug: Placebo for Cyproheptadine Other: Active Movement Practice (AMP) Other: Passive Cyclical Stretching Not Applicable

Detailed Description:

In this four arm parallel design you will be randomly assigned to one of 4 groups:

Group 1) cyproheptadine and active movement therapy, Group 2) placebo and active movement therapy, Group 3) cyproheptadine and passive stretching, or Group 4) placebo and passive stretching.

The groups will be blinded so neither you nor the research staff (or even the study doctor) will know which drug (Cyproheptadine or placebo) you receive. Only the RIC pharmacist will have access to this information until all participants complete the entire study. Although you and the research staff administering the training sessions will know if you have been assigned to the active movement practice (AMP) or passive cyclical stretching group, it is important not to discuss this information with the rater (evaluator) or the study doctor.

Cyproheptadine is an anti-serotonergic and anti spastic agent. It is expected to reduce the unwanted muscle hyper excitability (one measure of spasticity) common after stroke.

During the course of the treatment you will be required to make several visits per week to RIC to either be evaluated or participate in the treatment sessions. Evaluations last approximately 2 hours and will be performed at the beginning of weeks 1, 2, 3 and 4, during the middle of treatment (beginning of week 7), at the end of training (beginning of week 10) as well as a final follow-up visit one month after the end of treatment (beginning of week 14). The training sessions will occur from weeks 4 through week 9 and will involve 1.5-hr. sessions (1 hr training plus setup time) 3 times per week.

The investigators hypothesize that the group receiving the combined cyproheptadine and active movement therapy will have better outcomes than the groups receiving cyproheptadine or active movement therapy alone.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Altering Activation Patterns in the Distal Upper Extremity After Stroke
Study Start Date : November 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cyproheptadine + AMP

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.

Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.

Drug: Cyproheptadine

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.

Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug

Other Names:
  • cyproheptadine hydrochloride USP
  • cyproheptadine HCl
  • Periactin

Other: Active Movement Practice (AMP)
Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.

Placebo Comparator: Placebo for Cyproheptadine + Stretching

Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.

Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.

Dose will be titrated down to zero in the 2 weeks following treatment.

Drug: Placebo for Cyproheptadine

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.

Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug

Other Name: placebo

Other: Passive Cyclical Stretching
Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.

Active Comparator: Cyproheptadine + Stretching

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.

Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of passive cyclical stretching treatment (1 hour sessions 3x/week). Each session will involve 20 min of stretching followed by 10 minutes of rest.

Dose will be titrated down to zero in the 2 weeks following treatment.

Drug: Cyproheptadine

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.

Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug

Other Names:
  • cyproheptadine hydrochloride USP
  • cyproheptadine HCl
  • Periactin

Other: Passive Cyclical Stretching
Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.

Active Comparator: Placebo for Cyproheptadine + AMP

Placebo for Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy.

Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Chronic dose will be maintained throughout the 6 weeks of Active movement practice (AMP) treatment (1 hour sessions 3x/week). Dose will be titrated down to zero in the 2 weeks following treatment.

Drug: Placebo for Cyproheptadine

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.

Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug

Other Name: placebo

Other: Active Movement Practice (AMP)
Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.




Primary Outcome Measures :
  1. Change in mean completion time for Graded Wolf Motor Function Test (GWMFT) [ Time Frame: baseline and 9 weeks (immediately post intervention) ]
    GWMFT is comprised of 15 timed tasks. Maximum allowable time per task is 120 seconds.


Secondary Outcome Measures :
  1. Change in grip relaxation time (Following a maximum voluntary contraction (MVC) -- Time (s) required for muscle electromyographic (EMG) signals to reduce to within 3 SD of pre-MVC EMG activity.) [ Time Frame: baseline and 9 weeks (immediately post intervention) ]
    Following a maximum voluntary contraction (MVC) -- Time (s) required for muscle electromyographic (EMG) signals to reduce to within 3 SD of pre-MVC EMG activity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3)
  • Single stroke occurring at least 6 months prior to enrollment
  • Spasticity
  • Capacity to provide informed consent

Exclusion Criteria:

  • Excessive pain in paretic upper limb
  • Hemispatial neglect (as assessed by the Behavioral Inattention Test)
  • Apraxia (as assessed by the FABERS battery)
  • Botulinum toxin injection in the upper extremity within the past 6 months
  • Introduction of new anti-spasticity medication within the past 6 months
  • Orthopaedic impairments
  • History of seizure disorder
  • Other major health impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418949


Contacts
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Contact: Kristen M Triandafilou, MS 312-238-2993 triandafilou@ricres.org
Contact: Alexander Barry, MS 312-238-1435 abarry@sralab.org

Locations
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United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Alexander Barry, MS    312-238-2993    abarry@sralab.org   
Sub-Investigator: Derek G Kamper, PhD         
Principal Investigator: Elliot Roth, MD         
Sponsors and Collaborators
Shirley Ryan AbilityLab
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Study Director: Derek G Kamper, PhD North Carolina State University
Principal Investigator: Elliot Roth, MD Shirley Ryan AbilityLab

Publications:
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Responsible Party: Elliot Roth, Medical Director, Patient Recovery Unit, Attending Physician, RIC Professor & Chairman, PM&R, Northwestern Feinberg School of Medicine, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT02418949     History of Changes
Other Study ID Numbers: STU00078099
1R01HD075813-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elliot Roth, Shirley Ryan AbilityLab:
hand
rehabilitation
active movement training
passive cyclical stretching

Additional relevant MeSH terms:
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Stroke
Paresis
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Cyproheptadine
Antipruritics
Dermatologic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Anti-Allergic Agents