CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies

NCT01440452 | Terminated Results

• 1 other identifier: NA_00041441
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to see how different amounts of Functional Electrical Stimulation (FES) affect cycling on factors in blood and spinal cord in people with spinal cord inflammation.

Conditions

Inflammatory Myelopathies

Keywords

TM; MS; Spinal Cord Injury; Functional electrical stimulation; Rehabilitation; Growth factors; Cytokines

Outcome Measures

Primary Outcomes (1)

• CSF BDNF Levels in Subjects With Inflammatory Myelopathy

  We will measure cerebrospinal fluid (CSF) concentrations of BDNF in response to FES ergometry. We will investigate whether there is a correlation between plasma and CSF BDNF concentrations.

  Baseline

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)

  3 weeks

Study Arms (4)

Group A

EXPERIMENTAL

For 3 weeks, you will need to come to the International Center for Spinal Cord Injury at Kennedy Krieger Institute (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:

• Male, Female, age 18-65, all ethnic groups
• History of inflammatory myelopathy with onset at least 3 months prior
• No FES ergometer (i.e. RT300 or equivalent) use within 1 month
• Subject is medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
• Subject is legally able to make own health care decisions
• Access to telephone with texting capabilities
• English language proficiency

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 New York Heart Association (NYHA) Class III or IV, history of arrhythmia with hemodynamic instability.
• Uncontrolled hypertension (resting systolic 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 cerebrospinal fluid (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

• Johns Hopkins University: lead

Study Sites (1)

International Neurorehabilitation Institute

Lutherville, Maryland, 21093, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Myelitis; Spinal Cord Injuries

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Central Nervous System Infections; Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory 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
• Organization: Johns Hopkins Hospital

db@inirehab.com

4108284629

Study Officials

• Daniel Becker, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• 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 22, 2011
• First Posted: September 26, 2011
• Study Start: November 1, 2010
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 17, 2020
• Results First Posted: July 17, 2020

Record last verified: 2020-06

Locations

US (1)