Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03854214|
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : July 19, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Functional Electric Stimulation cycling Device: Passive cycling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The study will be performed as a randomized, parallel group trial to determine if the amount of changes in brain functional connectivity outcome measures (i.e., between network connectivity) is significantly different between the group of patients that perform FES cycling and another group of patients that perform passive (sham) cycling.
Official screening will be performed after participants consent by signing the study's consent form. Participants will be randomized into 2 groups: FES cycling (Group 1; n=24) and passive cycling (Group 2; n=24). The participants will undergo either an FES cycling or a passive cycling sessions for 4 weeks, 3 times a week. MRI will be performed on all participants at the beginning (prior to cycling sessions) and at the end of the 2nd and 4th weeks of the intervention program. ISNCSCI evaluations will be performed to coincide with the dates of MRI acquisitions, to determine the neurological level and the degree of sensory and motor impairments.
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||This study is a double-blinded randomized trial. Study physicians and research staff who perform study measurements on participants will be blinded from the intervention the study participants receive. Study participants will not be informed of the intervention he/she will receive. However, because of the nature of the interventions, study participant cannot be completely blinded to the treatment they will receive, as some participants may have residual motor and sensory functions and 'feel' which intervention they are receiving.|
|Primary Purpose:||Basic Science|
|Official Title:||Cortical Functional Connectivity as an Early Biomarker of Recovery in Spinal Cord Injury (Study 239481)|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
Active Comparator: Functional Electric Stimulation cycling
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on.
Device: Functional Electric Stimulation cycling
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Other Name: RT300 ergometer
Sham Comparator: Passive Cycling
The passive cycling group will use the same RT300 ergometer with stimulation off.
Device: Passive cycling
The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
Other Name: RT300 ergometer
- International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) score [ Time Frame: Change from baseline ISNCSCI scores at 2 weeks and 4 weeks after the start of intervention. ]Developed by the American Spinal Injury Association (ASIA) as a universal classification tool for spinal cord injury (SCI), the classification tool involves a sensory and motor examination to determine the neurological level of the injury and whether the injury is complete or incomplete. The tool also provides sensory and motor scores of upper and lower, as well as right and left sides of the body. The value of the total motor score ranges between 0-100, where 0 represents no residual motor function, and 100 represents normal motor function. The sensory scores consists of two sub-scores - specifically, light touch and pin-prick scores. The values of each sub-score ranges between 0-112, where 0 represents no residual sensory function, and 112 represents normal sensory function. The ISNCSCI defines neurological level as the most caudal level at which sensory and motor function are intact. The completeness of the injury is graded according to the ASIA Impairment Scale (AIS).
- Resting state fMRI functional connectivity [ Time Frame: Change from baseline functional connectivity at 2 weeks and 4 weeks after the start of intervention. ]RsfMRI functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population
- Resting state fMRI brain parcels [ Time Frame: Change from baseline fMRI brain parcels at 2 weeks and 4 weeks after the start of intervention. ]RsfMRI functional connectivity can also be used to identify functionally homogeneous brain regions, or parcels of the brain. The parcels' center of mass, average and variance of the BOLD signal time courses within the parcels can be used to characterize brain functional organization.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adult (18-65 years) men and women of all ethnic groups
- SCI, traumatic
- Thoracic neurological level, without the involvement of lower motor neurons.
- ASIA classification A-D
- Chronic injury: > 6 months from the injury
- Satisfactory general health
- No FES ergometer (i.e. RT300 or equivalent) use within 4 weeks.
- Ability to comply with procedures and follow-up
- Contra-indication to MR study (e.g., cardiac pacemaker, claustrophobia, aneurysm clip, etc.)
- History or clinical evidence of moderate or severe brain injury
- Major spine deformity (e.g. scoliosis, kyphosis, subluxation)
- Movement disorder or severe spasticity preventing ability to lay still for extended periods required for imaging.
- Women who are pregnant
- 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 with history of inability to tolerate electrical stimulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854214
|Contact: Ann S Choe, Ph.D.||email@example.com|
|United States, Maryland|
|Kennedy Krieger Institute, International Center for Spinal Cord Injury||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Cristina L Sadowsky, MD 443-923-9211 firstname.lastname@example.org|
|Principal Investigator:||Ann S Choe, Ph.D.||Johns Hopkins University|
|Responsible Party:||Ann Choe, Assistant Professor, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.|
|Other Study ID Numbers:||
R21NS104644 ( U.S. NIH Grant/Contract )
|First Posted:||February 26, 2019 Key Record Dates|
|Last Update Posted:||July 19, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||All research material will be kept confidential and any means of subject identification (name and history number) will be removed from all material for analysis or presentation. No identifying information will be made publicly available. In some cases, the study protocol, statistical analysis plan, individual scans, and all IPD that underlie results in a publication will be included in published papers or meeting papers or posters, but the identity of the subject in question will not be revealed.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||Starting immediately after publication|
|Access Criteria:||All IPD that underlie results in a publication will be available to the extent the related publication(s) allows it. However, under no circumstances any IPD that contains subject identification information will be shared.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|
Spinal Cord Injuries
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System