Non-invasive Brain Stimulation Paired With FES Cycling Post SCI

December 5, 2023 updated by: Western University, Canada

Exploring the Effect of Non-invasive Brain Stimulation Paired With Functional Electrical Stimulation to Improve Lower Extremity Function Following Incomplete Spinal Cord Injury

This project is randomized controlled trial which will explore the effect of pairing repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation (FES) Cycling on lower extremity function in people with incomplete spinal cord injury and compare the effects to each one of these interventions alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Following a spinal cord injury, people often have decreased strength and balance in their legs, making it difficult to walk. To improve leg function in people with spinal cold injuries, the investigators can use electrical stimulation on muscles while participants are cycling to increase the muscle activation and nerve connections. Another way to improve the nerve connections to the muscles is by stimulating the brain directly. Previous research has looked at the effects of each of these treatments, but they have not been used together. In this study, the investigators will pair both electrical stimulation on the legs during cycling with brain stimulation or a sham brain stimulation to improve recovery and determine if using these methods together results in better outcomes, such as increased walking speed. Participants will attend training sessions for six weeks, twice per week. Each person will first receive the active or sham brain stimulation at the beginning of the session for 30 minutes and then they will receive the electrical stimulation on their legs while cycling for 60 minutes. Participants will be evaluated before the start of the treatment, in the middle of the study, at the final session, and again two weeks after the last session of the treatment. Assessments will include clinical tests of gait, balance, and strength. Inertial Measurement Units (IMU) and a pressure sensor gait mat will be used to evaluate the gait and balance parameters.

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fereshteh Ghahremani, BSc
  • Phone Number: +1-647-622-4303
  • Email: fghahrem@uwo.ca

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 0A7
        • Recruiting
        • Parkwood Institute
        • Contact:
          • Fereshteh Ghahremani, BSc
          • Phone Number: +1-647-622-4303
          • Email: fghahrem@uwo.ca
        • Contact:
        • Sub-Investigator:
          • Siobhan Schabrun, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adult
  • having motor incomplete SCI with level C or D on the American Spinal Injury Association Impairment Scale (AIS) with the lesion at any level of the cord resulting from either traumatic or non-traumatic etiology who are at least one-year post-injury.
  • having non-progressive SCI
  • being able to walk independently for 10 meters without help from another person

Exclusion Criteria:

  • other orthopedic or neurological implications that affect the lower extremity function
  • contraindications to FES (e.g., implanted electronic devices, unhealed bone fractures, sever contractures, extreme osteoporosis or osteoarthritis)
  • contraindications to rTMS (e.g., metal implants, history of seizure, cochlear implants)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Participants of this group will receive active rTMS along with real FES cycling.
Device: repetitive transcranial magnetic stimulation (rTMS)
rTMS will be applied to primary motor cortex of the brain.
Device: functional electrical stimulation (FES) cycling
FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.
Sham Comparator: Control group
Participants of this group will receive sham rTMS along with real FES cycling.
Device: functional electrical stimulation (FES) cycling
FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants recruited from the total number screened
Time Frame: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.
8 weeks
Number of sessions attended by each participant
Time Frame: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.
8 weeks
Number of dropouts in each group
Time Frame: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.
8 weeks
Willingness of participants to undergo therapy
Time Frame: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol. The willingness of participation will be collected on an 11-point numerical rating scale with 'not at all willing' at 0, and 'very willing' at 10 (measured at baseline).
8 weeks
Incidence of treatment-emergent adverse events
Time Frame: 8 weeks
This outcome will be evaluated through descriptive data. Safety will be presented as any adverse reaction reported on verbal questioning at each session. The number of participants reporting adverse reactions, and the duration and severity of the adverse reactions will be reported.
8 weeks
Time taken to complete the recruitment of 12 participants
Time Frame: 8 weeks
This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking speed
Time Frame: 8 weeks
This instrumental outcome is collected using a pressure sensor gait mat.
8 weeks
Step length
Time Frame: 8 weeks
This instrumental outcome is collected using a pressure sensor gait mat.
8 weeks
Step width
Time Frame: 8 weeks
This instrumental outcome is collected using a pressure sensor gait mat.
8 weeks
Cadence
Time Frame: 8 weeks
This instrumental outcome is collected using a pressure sensor gait mat.
8 weeks
Sit-to-stand test
Time Frame: 8 weeks
This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
8 weeks
Postural sway test
Time Frame: 8 weeks
This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
8 weeks
Lower Extremity Motor Score (LEMS)
Time Frame: 8 weeks

A blinded physiotherapist will be hired to collect this clinical outcome.

Lower Extremity Motor Score is rated from 0 to 5* as follows:

0= Total paralysis

  1. Palpable or visible contraction
  2. Active movement, full range of motion (ROM) when gravity is eliminated
  3. Active movement, full ROM against gravity
  4. Active movement, full ROM against gravity, and moderate resistance in muscle-specific position
  5. (Normal) Active movement, full ROM against gravity, and full resistance in a muscle-specific position expected from a healthy person 5*= (Normal) Active movement, full ROM against gravity, and sufficient resistance to be considered normal if identified inhibiting factors (i.e., pain, disuse) were not present NT = Not testable (i.e., due to immobilization, sever pain that can prevent the grading of the patient, amputation of the limb, or contracture of >50% of the range of motion) Higher scores in this outcome mean better result.
8 weeks
Walking Index for Spinal Cord Injury (WISCI) II scale
Time Frame: 8 weeks
A blinded physiotherapist will be hired to collect this clinical outcome. Walking Index for Spinal Cord Injury version II scale is rated from 0 to 20 with the higher scores showing better results.
8 weeks
Timed Up and Go (TUG) test
Time Frame: 8 weeks
This instrumental outcome will be collected using Inertial Measurement Units (IMUs).
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rating of Change (GRC) scale
Time Frame: 8 weeks

Evaluation of the participants' impact will be collected through a GRC questionnaire in each assessment session.

Global Rating Scale will ask participants to rate their walking abilities and overall recovery of the lower limb function from the time that they began the treatment until now. This scale is rated from -7 to 7 as follows:

  • 7: A very great deal worse
  • 6: A great deal worse
  • 5: Quite a bit worse
  • 4: Moderately worse
  • 3: Somewhat worse
  • 2: A little bit worse

  • 1: A tiny bit worse (almost the same) 0: About the same

    • 1: A tiny bit better (almost the same)
    • 2: A little bit better
    • 3: Somewhat better
    • 4: Moderately better
    • 5: Quite a bit better
    • 6: A great deal better
    • 7: A very great deal better

Higher scores in this outcome mean better results.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Investigators

  • Study Director: Siobhan Schabrun, PhD, Western University, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 122650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD of this study will not be shared with other researchers of other studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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