Non-invasive Brain Stimulation Paired With FES Cycling Post SCI

ConditionIncomplete Spinal Cord Injury

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorWestern University, Canada

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

repetitive transcranial magnetic stimulation (rTMS)
Device
rTMS will be applied to primary motor cortex of the brain.
functional electrical stimulation (FES) cycling
Device
FES will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus.

Treatment groups

14 Participants

are divided into 2 treatment groups

Group A: Treatment groupExperimental treatment 2 interventions

Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

Time taken to complete the recruitment of 12 participants

This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.

Time frame

8 weeks

Proportion of participants recruited from the total number screened

This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the feasibility of the protocol.

Time frame

8 weeks

Number of sessions attended by each participant

This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.

Time frame

8 weeks

Number of dropouts in each group

This outcome will be evaluated through descriptive data. This outcome will be analyzed to evaluate the tolerability of the protocol.

Time frame

8 weeks

Secondary outcomes

Walking speed

This instrumental outcome is collected using a pressure sensor gait mat.

Time frame

8 weeks

Step length

This instrumental outcome is collected using a pressure sensor gait mat.

Time frame

8 weeks

Step width

This instrumental outcome is collected using a pressure sensor gait mat.

Time frame

8 weeks

Cadence

This instrumental outcome is collected using a pressure sensor gait mat.

Time frame

8 weeks

Other outcomes

Global Rating of Change (GRC) scale

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.

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western University, Canada

Lead sponsor

Source ClinicalTrials.gov

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