Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury

NCT01217047 | Terminated Phase 2 Results

• 1 other identifier: NA_00036348
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to study the effect of Functional Electrical Stimulation (FES) cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; Functional electrical stimulation; Rehabilitation; Growth factors; Cytokines

Outcome Measures

Primary Outcomes (2)

• CSF Brain Derived Neurotrophic Factor (BDNF) Level

  We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.

  Baseline

• CSF Brain Derived Neurotrophic Factor (BDNF) Level

  We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.

  At 3 weeks

Secondary Outcomes (7)

• Mood Assessment

  3 weeks

• Spasticity Testing Using the Modified Ashworth Scale (MAS)

  Baseline

• CSF Growth Factor Quantification

  Baseline

• Serum Brain Derived Neurotrophic Factor (BDNF) Level

  Baseline

• Spasticity Testing Using the Modified Ashworth Scale (MAS)

  At 3 weeks

Study Arms (4)

Group A

EXPERIMENTAL

For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.

Device: FES Cycling; Procedure: Lumbar puncture; Behavioral: Mood assessment

Group B

EXPERIMENTAL

For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.

Device: FES Cycling; Procedure: Lumbar puncture; Behavioral: Mood assessment

Group C

EXPERIMENTAL

For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.

Device: FES Cycling; Procedure: Lumbar puncture; Behavioral: Mood assessment

Group D

EXPERIMENTAL

For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.

Device: Cycling without FES; Procedure: Lumbar puncture; Behavioral: Mood assessment

Interventions

FES Cycling DEVICE

You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.

Also known as: RT300-SL, from Restorative Therapies, INC.

Group A; Group B; Group C

Cycling without FES DEVICE

You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.

Also known as: RT300-SL, from Restorative Therapies, INC.

Group D

Lumbar puncture PROCEDURE

The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).

Also known as: Spinal tap

Group A; Group B; Group C; Group D

Mood assessment BEHAVIORAL

If you do not already have an account, you will be signed up with "Mood24/7" (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period.

Also known as: Mood24/7

Group A; Group B; Group C; Group D

Eligibility Criteria

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

You may qualify if:

• History of traumatic spinal cord injury sustained at least 6 months prior
• Complete spinal cord injury at any level American Spinal Injury Association (ASIA) impairment scale A
• No use of functional electrical stimulation within 3 months
• Medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
• Legally able to make own health care decisions

You may not qualify if:

• Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke, history of arrhythmia with hemodynamic instability
• Uncontrolled hypertension (resting systolic blood pressure (BP) \>160mmHg or diastolic BP \>100mmHg consistently)
• Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability
• Unstable long bone fractures of the lower extremities
• Subjects who are unwilling to agree to two (2) CSF examinations (lumbar punctures)
• Presence of cardiac pacemaker and/or defibrillator
• Presence of cancer
• History of epileptic seizures
• Subjects having a Stage 2 or greater sacral decubitus ulcer
• Women who are pregnant
• Active drug or alcohol use or dependence

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Daniel Becker, M.D.
• Organization: Kennedy Krieger Institute

dbecke13@jhu.edu

888-923-9222

Study Officials

• Daniel Becker, M.D.

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 27, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-01

Locations

US (1)