Altering Activation Patterns Post-stroke

Shirley Ryan AbilityLab

Status: Active, not recruiting

Conditions: Stroke; Muscle Spasticity; Hemiparesis

Treatments: Other: Active Movement Practice (AMP); Other: Passive Cyclical Stretching; Drug: Placebo for Cyproheptadine; Drug: Cyproheptadine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02418949

STU00078099

1R01HD075813-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 4 patient groups, including a placebo group

Cyproheptadine + AMP

Experimental group

Description:

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.

Treatment:

Drug: Cyproheptadine

Other: Active Movement Practice (AMP)

Placebo for Cyproheptadine + Stretching

Placebo Comparator group

Description:

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:

Drug: Placebo for Cyproheptadine

Other: Passive Cyclical Stretching

Cyproheptadine + Stretching

Active Comparator group

Description:

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:

Drug: Cyproheptadine

Other: Passive Cyclical Stretching

Placebo for Cyproheptadine + AMP

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo for Cyproheptadine

Other: Active Movement Practice (AMP)