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Cyproheptadine + Passive Cyclical Stretching + Active Movement Practice for Post-Stroke Paresis, Hemiparesis, and Muscle Spasms

N/A
Waitlist Available
Led By Elliot Roth, MD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 9 weeks (immediately post intervention)
Awards & highlights

Study Summary

This trial looks at a new way to help people who have had a stroke. It uses medicine and physical activity to help people get back movement and strength.

Eligible Conditions
  • Hemiparesis
  • Stroke
  • Muscle Spasms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 9 weeks (immediately post intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 9 weeks (immediately post intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT)
Secondary outcome measures
Change in Grip Relaxation Time (Following a Maximum Voluntary Contraction (MVC)

Side effects data

From 2010 Phase 2 trial • 14 Patients • NCT01076283
29%
sedation
14%
yellow urine
14%
constipation
14%
dental pain
14%
sleepness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cyproheptadine
Baclofen

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cyproheptadine + AMPExperimental Treatment2 Interventions
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.
Group II: Cyproheptadine + StretchingActive Control2 Interventions
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.
Group III: Placebo for Cyproheptadine + AMPActive Control2 Interventions
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.
Group IV: Placebo for Cyproheptadine + StretchingPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyproheptadine
FDA approved

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,672,486 Total Patients Enrolled
8 Trials studying Hemiparesis
486 Patients Enrolled for Hemiparesis
Shirley Ryan AbilityLabLead Sponsor
194 Previous Clinical Trials
16,816 Total Patients Enrolled
4 Trials studying Hemiparesis
89 Patients Enrolled for Hemiparesis
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,506,780 Total Patients Enrolled
5 Trials studying Hemiparesis
233 Patients Enrolled for Hemiparesis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
2011 IEEE International Conference on Rehabilitation RoboticsJournal
Use of an Electromyographically Driven Hand Orthosis for Training After Stroke
Ochoa, J. M., Molly Listenberger, Derek G. Kamper, and Sang Wook Lee. 2011. “Use of an Electromyographically Driven Hand Orthosis for Training After Stroke”. 2011 IEEE International Conference on Rehabilitation Robotics. IEEE. doi:10.1109/icorr.2011.5975382.
2009 Annual International Conference of the IEEE Engineering in Medicine and Biology SocietyJournal
Development of a Portable Actuated Orthotic Glove to Facilitate Gross Extension of the Digits for Therapeutic Training After Stroke
Ochoa, J.M., Yicheng Jia, D. Narasimhan, and D.G. Kamper. 2009. “Development of a Portable Actuated Orthotic Glove to Facilitate Gross Extension of the Digits for Therapeutic Training After Stroke”. 2009 Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE. doi:10.1109/iembs.2009.5333630.
IEEE Transactions on Neural Systems and Rehabilitation EngineeringJournal
Benefits of Using a Voice and Emg-driven Actuated Glove to Support Occupational Therapy for Stroke Survivors
Thielbar, Kelly O., Kristen M. Triandafilou, Heidi C. Fischer, Jake M. O'Toole, Molly L. Corrigan, Jose M. Ochoa, Mary Ellen Stoykov, and Derek G. Kamper. 2017. “Benefits of Using a Voice and Emg-driven Actuated Glove to Support Occupational Therapy for Stroke Survivors”. IEEE Transactions on Neural Systems and Rehabilitation Engineering. Institute of Electrical and Electronics Engineers (IEEE). doi:10.1109/tnsre.2016.2569070.
Archives of Physical Medicine and RehabilitationJournal
Survivors of Chronic Stroke Experience Continued Impairment of Dexterity but Not Strength in the Nonparetic Upper Limb
Barry, Alexander J., Kristen M. Triandafilou, Mary Ellen Stoykov, Naveen Bansal, Elliot J. Roth, and Derek G. Kamper. 2020. “Survivors of Chronic Stroke Experience Continued Impairment of Dexterity but Not Strength in the Nonparetic Upper Limb”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2020.01.018.
~10 spots leftby Apr 2025
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