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A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity

Primary Purpose

Spinal Cord Injuries, Muscle Pareses, Fall

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Activity-based rehabilitation+electrical stimulation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A traumatic or non-traumatic, non-progressive motor iSCI [American Spinal Injury Association Impairment Scale (AIS) rating of C or D]; More than 1-year post-injury; ≥18 years old; BBS score <46; Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke) Exclusion Criteria: Neurological lesion levels below T12 ; Severe spasticity in the legs; Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee; Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation); A pressure sore (>grade 2) on the pelvis or trunk where the safety harness is applied; Pregnancy; History of epilepsy; Contraindications for electrical stimulation (i.e. implanted electronic device, active cancer or radiation in past months, epilepsy, skin rash/wound at a potential electrode site)

Sites / Locations

  • Toronto Rehabilitation Institute-Lyndhurst Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FES+TSCS (combined) neuromodulation group

FES group

Arm Description

For the combined neuromodulation with VFT group, the sub-motor threshold, open-loop TSCS will be coupled with closed-loop FES of ankle muscles during VFT. For this purpose, 2 electrical stimulators, one for each leg will stimulate SOL and TA muscles bilaterally while open-loop tonic lumbar TSCS will be applied at an intensity producing paresthesia in most of the lower-limb dermatomes

For the FES with VFT group, participants will receive visual feedback regarding their center of pressure location during four games with varying levels of difficulty and FES will be applied bilaterally to SOL and TA via a closed-loop system.

Outcomes

Primary Outcome Measures

Mini-Balance Evaluation Systems Test (mini-BESTest)
evaluates different components of postural control including anticipatory, reactive postural control, sensory orientation, and dynamic gait. It has high test-retest reliability, concurrent and convergent validity in individuals with iSCI.
10-meter Walk Test (10MWT)
performance-based measure to assess mobility and walking speed over a short distance.
Motor evoked potentials (MEP)
To measure neuroplasticity, we will record changes in the MEPs for the SOL and TA induced by TMS over the leg representation of the motor cortex

Secondary Outcome Measures

Activities-specific Balance Confidence (ABC) Scale
self-reported questionnaire that evaluates balance confidence while performing 16 different mobility tasks such as walking around the house, sweeping the floor, climbing up and down the stairs, walking on a ramp and negotiating escalators
Falls Efficacy Scale - International (FES-I)
16-item self-reported questionnaire that measures fear of falling during basic and demanding daily life activities

Full Information

First Posted
July 4, 2023
Last Updated
July 11, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05940636
Brief Title
A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity
Official Title
A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity After Incomplete SCI
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many people with partial damages in their spinal cord (iSCI) have physical impairments such as muscle paralysis in legs which make standing balance difficult. Poor balance control often leads to falls, injuries, and hospitalization. Therefore, improvement of standing balance is an important therapeutic goal for these individuals. Our team has shown that a therapy called visual feedback training (VFT) can improve standing balance by allowing individuals with iSCI to actively participate and follow visual feedback of their body sway on a screen like a computer game. We have also found that the application of low-energy electrical pulses to weak muscles called functional electrical stimulation (FES) during VFT can enhance the training effects. Recently, transcutaneous spinal cord stimulation (TSCS) has been discussed as a promising technique to further promote the rehabilitation effects after SCI by enhancing the connectivity between the brain and spinal cord and within the spinal pathways. However, to date, the potential of combining the two techniques (TSCS+FES) to improve the standing balance remains unknown. In this study, through the completion of a clinical trial, we will investigate the effects of an intervention that combines lumbar TSCS with FES of ankle muscles during VFT on the functional and neurophysiological outcomes in individuals living with iSCI. Participants will be randomly allocated to receive combined TSCS with FES or FES alone during VFT for 12 training sessions over 4 weeks. We expect that the new therapy would further improve balance and strengthen the neural connections between the brain and muscles. The expected changes in the neural connections will be measured by recording electrical signals from the lower limb muscles following stimulation of the motor region of the brain. Results of this study will be used for a larger-scale study in people with iSCI to improve balance and reduce falls during their daily life activities.
Detailed Description
This is a single-center, randomized controlled trial to test the effects of a novel neuromodulation program on balance performance and neuroplasticity in individuals with iSCI. Participants will be randomly assigned to 2 equal groups labeled as (1) FES with VFT, and (2) combined neuromodulation with VFT. They will complete 8 training sessions over 4 weeks (2 sessions/week). For the FES with VFT group, participants will receive visual feedback regarding their center of pressure location during four games with varying levels of difficulty and FES will be applied bilaterally to SOL and TA via a closed-loop system. Each exercise will be completed 3 times per training session. For the combined neuromodulation with VFT group, the sub-motor threshold, open-loop TSCS will be coupled with closed-loop FES of ankle muscles during VFT. For this purpose, 2 electrical stimulators, one for each leg will stimulate SOL and TA muscles bilaterally while open-loop tonic lumbar TSCS will be applied at an intensity producing paresthesia in most of the lower-limb dermatomes. The range of FES stimulation intensity will vary between the minimal contraction threshold and 80% of the maximal tolerable threshold for each participant during games depending on the instant location of the participant's center of pressure and the location of the desired target during the game. All dependent variables will be assessed prior, immediately after, and 6-weeks after the end of intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Muscle Pareses, Fall

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FES+TSCS (combined) neuromodulation group
Arm Type
Experimental
Arm Description
For the combined neuromodulation with VFT group, the sub-motor threshold, open-loop TSCS will be coupled with closed-loop FES of ankle muscles during VFT. For this purpose, 2 electrical stimulators, one for each leg will stimulate SOL and TA muscles bilaterally while open-loop tonic lumbar TSCS will be applied at an intensity producing paresthesia in most of the lower-limb dermatomes
Arm Title
FES group
Arm Type
Active Comparator
Arm Description
For the FES with VFT group, participants will receive visual feedback regarding their center of pressure location during four games with varying levels of difficulty and FES will be applied bilaterally to SOL and TA via a closed-loop system.
Intervention Type
Other
Intervention Name(s)
Activity-based rehabilitation+electrical stimulation
Intervention Description
Balance training will occur three times per week for four weeks, totaling 12 two-hour sessions. In both groups, you will be asked to stand on a force plate while playing visual feedback training (VFT) games as part of the standing balance training. A force plate is similar to a bathroom scale that you can stand on which measures your body sway during movement. Visual feedback training (VFT) is a type of activity that includes weight-shifting movements in the upright stance. VFT will be done in both groups. There will be different games as shown in figure 1 and the order of the games will be randomly chosen in each session. During each game, there will be targets that will be presented on the screen and you will have to navigate toward them . You will be able to rest between games as needed.
Primary Outcome Measure Information:
Title
Mini-Balance Evaluation Systems Test (mini-BESTest)
Description
evaluates different components of postural control including anticipatory, reactive postural control, sensory orientation, and dynamic gait. It has high test-retest reliability, concurrent and convergent validity in individuals with iSCI.
Time Frame
pre- immidiately post- 6 weeks follow up
Title
10-meter Walk Test (10MWT)
Description
performance-based measure to assess mobility and walking speed over a short distance.
Time Frame
pre- immidiately post- 6 weeks follow up
Title
Motor evoked potentials (MEP)
Description
To measure neuroplasticity, we will record changes in the MEPs for the SOL and TA induced by TMS over the leg representation of the motor cortex
Time Frame
pre- immidiately post- 6 weeks follow up
Secondary Outcome Measure Information:
Title
Activities-specific Balance Confidence (ABC) Scale
Description
self-reported questionnaire that evaluates balance confidence while performing 16 different mobility tasks such as walking around the house, sweeping the floor, climbing up and down the stairs, walking on a ramp and negotiating escalators
Time Frame
pre- immidiately post- 6 weeks follow up
Title
Falls Efficacy Scale - International (FES-I)
Description
16-item self-reported questionnaire that measures fear of falling during basic and demanding daily life activities
Time Frame
pre- immidiately post- 6 weeks follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A traumatic or non-traumatic, non-progressive motor iSCI [American Spinal Injury Association Impairment Scale (AIS) rating of C or D]; More than 1-year post-injury; ≥18 years old; BBS score <46; Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke) Exclusion Criteria: Neurological lesion levels below T12 ; Severe spasticity in the legs; Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee; Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation); A pressure sore (>grade 2) on the pelvis or trunk where the safety harness is applied; Pregnancy; History of epilepsy; Contraindications for electrical stimulation (i.e. implanted electronic device, active cancer or radiation in past months, epilepsy, skin rash/wound at a potential electrode site)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kei Masani, PhD
Phone
416-597-3422
Ext
6098
Email
k.masani@utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Shirin Tajalli, PhD
Phone
416-597-3422
Ext
5301
Email
Shirin.tajalli@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kei Masani, PhD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute-Lyndhurst Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
m4g3v9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kei Masani, PhD
Phone
416-597-3422
Ext
6098
Email
k.masani@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Shirin Tajalli, PhD
Phone
6474108068
Email
shirin.tajalli@utoronto.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity

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