Impact of Persistent Conductances on Motor Unit Firing in SCI

NCT02136823 | Unknown

• 1 other identifier: STU00012823
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being done to measure the differences between the electrical activity of muscles and /single muscle fibers in individuals with long-term spinal cord injury and neurologically intact individuals without spinal cord injury. This study is also being done to find out if muscle and /single muscle fiber electrical activity, voluntary strength, reflex measurements, and/or spasms are changed after a single, oral dose of three commonly prescribed drugs, Rilutek®, isradipine, and Namenda®. These medications are approved by the FDA for treatment of disorders other than the control of spasms and strength. In this study, they are being used in an experimental manner. Finally, this study is also being done to find out whether or not a brief stretching exercise influences reflex measurements. The main hypothesis of this study is that aberrant current activity in spinal motoneurons contributes to spastic hyper-reflexia following chronic spinal cord injury.

Conditions

Chronic Spinal Cord Injury

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• Changes in reflex excitability measures following drug administration

  up to 8 hours

• Change in reflex excitability measures after muscle stretching intervention

  up to 6 hours

Study Arms (5)

sugar pill

PLACEBO COMPARATOR

sugar pill, oral administration, placebo capsule

Drug: sugar pill

riluzole

EXPERIMENTAL

50mg tablet, single oral dose, one day (single dose)

Drug: Riluzole

isradipine

EXPERIMENTAL

5mg capsule, single oral dose, one day (single dose)

Drug: Isradipine

memantine

EXPERIMENTAL

5mg tablet, single oral dose, one day (single oral dose)

Drug: Memantine

therapeutic stretching

EXPERIMENTAL

Manual therapeutic stretching of tested muscle by licensed clinician

Procedure: Therapeutic muscle stretching

Interventions

sugar pill DRUG

Also known as: placebo

sugar pill

Riluzole DRUG

Also known as: Rilutek

riluzole

Isradipine DRUG

isradipine

Memantine DRUG

Also known as: Namenda

memantine

Therapeutic muscle stretching PROCEDURE

therapeutic stretching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with Spinal Cord Injury:
• Clinical diagnosis of motor-incomplete chronic (\>1yr) SCI between 18-65 yrs old
• non-progressive lesion between C5-T1
• movement impairment (including reduced volitional elbow flexion against gravity)
• reduced active range of motion
• medically stable
• have medical clearance from their primary internists or physiatrists to participate in experiments involving drug administration.
• Control Subjects: healthy with no history of neurological injury or disease.
• have medical clearance from their primary internists or physiatrists to participate in experiments involving drug administration.

You may not qualify if:

• Under age 18yrs (children)
• Pregnancy or breastfeeding (women who are pregnant or nursing will be excluded)
• Spinal cord injury below T10 due to potential peripheral nerve damage/cauda equina injury
• concurrent medical illnesses, infections, upper extremity pain, inflammation or recent injury
• significant cardiovascular disease (including arrhythmias that require pacemakers, hypertension or hypotension)
• history of cardiovascular or pulmonary complications (including significant obstruction and/or restrictive lung diseases)
• metabolic (endocrine, hepatic) or renal dysfuction
• traumatic head injury
• orthopedic disease or injury
• diagnosis of other neurological disease
• Concurrent use of antispasticity medications
• concurrent use of medications that may interact with the test agents
• previous sensitivity to the test agents or their components

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Sugars; Riluzole; Isradipine; Memantine

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Carbohydrates; Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dihydropyridines; Pyridines; Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 13, 2014
• Study Start: June 1, 2009
• Primary Completion: May 1, 2015
• Last Updated: May 13, 2014

Record last verified: 2014-05