Altering Activation Patterns Post-stroke

NCT02418949 | Completed Results

• 2 other identifiers: STU000780991R01HD075813-01A1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Muscle Spasticity; Hemiparesis

Keywords

hand; rehabilitation; active movement training; passive cyclical stretching

Outcome Measures

Primary Outcomes (1)

• Change in Mean Completion Time for Graded Wolf Motor Function Test (GWMFT)

  GWMFT is a clinical outcome measure comprised of 15 timed tasks focusing on upper extremity function. Maximum allowable time per task is 120 seconds.

  baseline and 9 weeks (immediately post intervention)

Secondary Outcomes (1)

• Change in Grip Relaxation Time (Following a Maximum Voluntary Contraction (MVC)

  baseline and 9 weeks (immediately post intervention)

Study Arms (4)

Cyproheptadine + AMP

EXPERIMENTAL

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; Other: Active Movement Practice (AMP)

Placebo for Cyproheptadine + Stretching

PLACEBO COMPARATOR

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; Other: Passive Cyclical Stretching

Cyproheptadine + Stretching

ACTIVE COMPARATOR

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; Other: Passive Cyclical Stretching

Placebo for Cyproheptadine + AMP

ACTIVE COMPARATOR

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; Other: Active Movement Practice (AMP)

Interventions

Cyproheptadine DRUG

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

Also known as: cyproheptadine hydrochloride USP, cyproheptadine HCl, Periactin

Cyproheptadine + AMP; Cyproheptadine + Stretching

Placebo for Cyproheptadine DRUG

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

Also known as: placebo

Placebo for Cyproheptadine + AMP; Placebo for Cyproheptadine + Stretching

Active Movement Practice (AMP) OTHER

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.

Cyproheptadine + AMP; Placebo for Cyproheptadine + AMP

Passive Cyclical Stretching OTHER

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.

Cyproheptadine + Stretching; Placebo for Cyproheptadine + Stretching

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• Ochoa JM, Listenberger M, Kamper DG, Lee SW. Use of an electromyographically driven hand orthosis for training after stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975382. doi: 10.1109/ICORR.2011.5975382.

  PMID: 22275586 BACKGROUND

• Ochoa J, Dev Narasimhan YJ, Kamper DG. Development of a portable actuated orthotic glove to facilitate gross extension of the digits for therapeutic training after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6918-21. doi: 10.1109/IEMBS.2009.5333630.

  PMID: 19964456 BACKGROUND

• Thielbar KO, Triandafilou KM, Fischer HC, O'Toole JM, Corrigan ML, Ochoa JM, Stoykov ME, Kamper DG. Benefits of Using a Voice and EMG-Driven Actuated Glove to Support Occupational Therapy for Stroke Survivors. IEEE Trans Neural Syst Rehabil Eng. 2017 Mar;25(3):297-305. doi: 10.1109/TNSRE.2016.2569070. Epub 2016 May 17.

  PMID: 27214905 BACKGROUND

• Kamper D, Barry A, Bansal N, Stoykov ME, Triandafilou K, Vidakovic L, Seo N, Roth E. Use of cyproheptadine hydrochloride (HCl) to reduce neuromuscular hypertonicity in stroke survivors: A Randomized Trial: Reducing Hypertonicity in Stroke. J Stroke Cerebrovasc Dis. 2022 Oct;31(10):106724. doi: 10.1016/j.jstrokecerebrovasdis.2022.106724. Epub 2022 Aug 30.

  PMID: 36054974 DERIVED

• Barry AJ, Triandafilou KM, Stoykov ME, Bansal N, Roth EJ, Kamper DG. Survivors of Chronic Stroke Experience Continued Impairment of Dexterity But Not Strength in the Nonparetic Upper Limb. Arch Phys Med Rehabil. 2020 Jul;101(7):1170-1175. doi: 10.1016/j.apmr.2020.01.018. Epub 2020 Feb 28.

  PMID: 32113974 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Paresis

Interventions

Cyproheptadine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Alexander Barry
• Organization: Shirley Ryan AbilityLab

abarry@sralab.org

3122381435

Study Officials

• Derek G Kamper, PhD

  North Carolina State University

  STUDY DIRECTOR

• Elliot Roth, MD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Patient Recovery Unit, Attending Physician, RIC Professor & Chairman, PM&R, Northwestern Feinberg School of Medicine

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: April 17, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: March 23, 2022
• Last Updated: March 31, 2026
• Results First Posted: July 13, 2021

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)