Improving SCI Rehabilitation Interventions by Retraining the Brain
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| ClinicalTrials.gov Identifier: NCT03892746 |
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Recruitment Status :
Recruiting
First Posted : March 27, 2019
Last Update Posted : January 14, 2022
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Sponsor:
The Cleveland Clinic
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ela B. Plow, The Cleveland Clinic
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Brief Summary:
The Long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for cervical Spinal Cord Injury survivors.
This Study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 15 sessions over several weeks up to 8 weeks.
The Study will include the following site visits:
- Eligibility Screening and Informed Consent Visit.
- Four testing visit in which motor function of the upper limb and neurophysiology will be measured
- Fifteen intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation
- Repeat testing of motor function and neurophysiology of the upper limb following completion of intervention visits
- a Follow-up visit completed 3 months after the completion of interventions
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Spinal Cord Injruy | Device: Active tDCS + task oriented practice Device: Sham tDCS + task oriented practice | Phase 1 Phase 2 |
This is a phase I/II Multi-site Clinical Trial. In this phase I/II randomized controlled study, 49 cervical spinal patients with upper limb impairments will receive non-invasive brain stimulation tDCS (Transcranial Direct Current Stimulation) to the area in the brain controlling the weaker muscle of the weakest upper limb while receiving training for 15 sessions over several weeks up to 8 weeks. The primary outcome will be motor limb impairment, and secondary outcomes will be tests of functional ability, spinal excitability, and strength and dexterity. Safety and feasibility of pairing tDCS with rehabilitation will also be explored and include adverse effects, subject/investigator blinding, and attrition to 3 month follow-up.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 49 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | In this phase I/II clinical trial, an anticipated 49 subjects will receive 15 sessions of upper limb training while receiving either active tDCS or sham tDCS to the target in the brain devoted to the weaker triceps of the weaker upper limb. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Subjects will be randomly assigned by the Cleveland Clinic biostatistician to receive either active or sham tDCS. The tDCS will be pre-programmed with codes for active and sham stimulation. The code will be given to the intervention team by the biostatistician. Investigators analyzing functional outcome data and neurophysiology data will receive coded data that conceals the identity of the subject. |
| Primary Purpose: | Treatment |
| Official Title: | Improving SCI Rehabilitation Interventions by Retraining the Brain |
| Actual Study Start Date : | July 12, 2019 |
| Estimated Primary Completion Date : | September 29, 2023 |
| Estimated Study Completion Date : | September 29, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Rehabilitation
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Active tDCS + task oriented practice |
Device: Active tDCS + task oriented practice
Participants in this arm will receive active tDCS(2mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks. |
| Sham Comparator: Sham tDCS + task oriented practice |
Device: Sham tDCS + task oriented practice
Participants in this arm will receive sham tDCS(0mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks |
Primary Outcome Measures :
- Change in Upper Extremity Motor Score(UEMS) with Manual Muscle Testing [ Time Frame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. ]UEMS is used in Spinal Cord injury to identify strength(muscle power) in patients with spinal cord injury.
- Change in GRASSP [ Time Frame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. ]GRASSP is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients
- Change in Canadian Occupational Performance Measure (COPM) [ Time Frame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. ]COPM is used to measure participation restrictions of Spinal Cord Injury Subjects
- Change in Spinal Cord Independence Measure(SCIM) [ Time Frame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. ]SCIM is a spinal cord injury measure that identifies activity limitations of self-care
- Change in excitability of cortical and corticospinal physiology (TMS) [ Time Frame: Baseline (0 weeks and 3 weeks) and after intervention(up to 8 weeks) ]Transcranial magnetic stimulation will be used to test cortical and corticospinal physiology. The threshold of the biceps and triceps of the weaker upper limb will be collected. Motor maps dedicated to the biceps and triceps of the weaker upper limb will be collected. These motor maps will show the area and strength of neuronal control to the biceps and triceps of the weaker upper limb.
- Change in excitability of spinal physiology (H-reflex) [ Time Frame: Baseline (0 weeks and 3 weeks) and after intervention(up to 8 weeks) ]Spinal pathways will be tested using peripheral nerve testing. During this testing H-reflex will be collected.
- Change in Capabilities of Upper Extremity Test(CUE-T) [ Time Frame: Baseline (0 weeks and 3 weeks), after intervention(up to 8 weeks) and after end of 3 months of follow-up. ]CUE-T is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients
Other Outcome Measures:
- Safety and Feasibility [ Time Frame: Through entirity of study ]In line with this phase I/II clinical trial, safety and feasibility will be tested throughout this study. Vital signs (blood pressure, heart rate, respirations, blood oxygen saturation) will be recorded for each study session. During Intervention sessions we will ask a tDCS adverse effects questionnaire at the end of each session.
- TMS safety questionnaire [ Time Frame: Through entirity of study ]A TMS safety questionnaire will be asked at the end of the preintervention tests and the post intervention testing visit.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients with incomplete (having sparing to muscles in the upper extremities below the level of injury) C1-C8 SCI
- at least 1 year post injury
- weakness of the triceps or biceps muscle in the weaker upper limb, defined as a clinically detectable difference in power compared to the power of the spared antagonist(biceps and triceps respectively) muscle, i.e., at least one muscle grade lower on the MRC scale.
Exclusion Criteria:
- contraindications to tDCS and TMS including: pacemaker, metal in the skull, seizure history, pregnancy.
- pressure ulcers
- traumatic brain injury (TBI), diagnosed based upon acute injury Rancho scale <5 or positive MRI/CT findings at the time of injury will also be excluded to prevent confounding of TMS metrics.
- excessive tone/spasticity and severe contractures or soft tissue shortening at the elbow/wrist
- participating in ongoing upper-limb therapies
Information from the National Library of Medicine
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): NCT03892746
Contacts
| Contact: Kyle J. O'Laughlin, MS | 216-445-7841 | olaughk@ccf.org | |
| Contact: Ela Plow, PhD | 216-445-4589 | plowe2@ccf.org |
Locations
| United States, New Jersey | |
| Kessler Foundation | Recruiting |
| West Orange, New Jersey, United States, 07052 | |
| Contact: Leighann Martinez, BA 973-324-3557 LMartinez@kesslerfoundation.org | |
| Contact: Gail Forrest, PhD 973-324-3518 gforrest@kesslerfoundation.org | |
| Principal Investigator: Gail Forrest, PhD | |
| United States, Ohio | |
| Louis B. Stokes Cleveland VA Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Kyle J. O'Laughlin, MS 216-445-7841 olaughk@ccf.org | |
| Contact: Svetlana Pundik, PhD | |
| Principal Investigator: Svetlana Pundik, PhD | |
| The MetroHealth System | Not yet recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Anne Bryden, PhD 216-957-3594 anne.bryden@case.edu | |
| Contact: David Cunningham, PhD 216-957-3349 dxc536@case.edu | |
| Lerner Research Institute; Cleveland Clinid Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Kyle J O'Laughlin, MS 216-445-7841 olaughk@ccf.org | |
| Contact: Ela Plow, PhD 216-445-4589 plowe2@ccf.org | |
| Principal Investigator: Ela Plow, PhD | |
Sponsors and Collaborators
The Cleveland Clinic
United States Department of Defense
Investigators
| Principal Investigator: | Ela Plow, PhD | The Cleveland Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ela B. Plow, Principal Investigator, Staff, Neural Control Lab, Dept. of Biomedical Engineering, The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT03892746 |
| Other Study ID Numbers: |
18-972 |
| First Posted: | March 27, 2019 Key Record Dates |
| Last Update Posted: | January 14, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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.: | No |
Keywords provided by Ela B. Plow, The Cleveland Clinic:
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Cervical Spinal Cord Injury tDCS Transcranial Direct Current Stimulation |
Upper limb Rehabilitation Brain Stimulation |