SCI - Spinal Cord InjuryNCT06494059
A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients
A study testing Intermittent theta burst stimulation (iTBS), Functional electrical stimulation (FES) and Transcutaneous spinal cord stimulation (TSCS) in people with SCI - Spinal Cord Injury, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI)… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Intermittent theta burst stimulation (iTBS), Functional electrical stimulation (FES) and Transcutaneous spinal cord stimulation (TSCS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female subjects
- At least 18 years old and no older than 70 years old at the time of enrollment.
- Able-bodied subjects
- Traumatic spinal cord injury
- Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory;
- Lower limb target: neurological level at or above Thoracic 10 level, with residual lower limb function; AIS B, C or D impairment grade primary could ambulate;
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- Trunk target: neurological at or above Thoracic 5, AIS A, B, C or D impairment grade, primary wheelchair user
- Spinal cord injury sustained more than 6 months prior to study.
- Movement/excitability/etc:
- Upper limb target: Has detectable residual connection in upper-limb muscles in at least one side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) and a visible contraction when functional electrical stimulation (FES) is applied in the hand or wrist muscle at baseline.
- Lower limb target: Has detectable residual connection in lower-limb muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in lower limb ankle plantar or dorsiflexor muscle at baseline.
- Trunk target: Has detectable residual connection in trunk muscles in at least one side confirmed by voluntary EMG or detectable MEP and a visible contraction when FES is applied in trunk muscle at baseline.
- Able to commit to intervention and assessment sessions over a maximum duration of 2 months.
Who cannot join
- Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
- Has severe spasticity that could prevent the study protocol as determined by the investigator.
- Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
- Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease.
- Has a poorly managed autonomic dysreflexia that could be triggered by transcranial magnetic stimulation (TMS), FES, or TSCS.
- Has a history of prior intracranial surgery or known medical risks that would limit TMS protocols.
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- Has a history of epilepsy, convulsion or seizures.
- Individuals with metal implants in their head or spine near the sites to be stimulated and other implantable devices (e.g., cochlear implants) in the body that could be affected by TMS or TSCS.
- Has implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation or VNS).
- Has a cardiac pacemaker or intracardiac lines.
- Has peripheral neuropathy, including diabetic polyneuropathy and entrapment neuropathy.
- Has urinary tract infection, unhealed fracture, contracture, and pressure sore as determined by Braden Scale value of 14 and below.
- Individuals who require therapy or other care that could interfere with participation in the study.
- Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
- Individuals with substance disorders, including alcoholism and drug abuse.
- Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
- In the opinion of the investigators, the study is not safe or appropriate for the participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Deena Cilien, DPT, 305-243-9301, dcilien@med.miami.edu
Matija Milosevic, PhD
About this study
The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- Intermittent theta burst stimulation (iTBS), Functional electrical stimulation (FES), Transcutaneous spinal cord stimulation (TSCS), Sham Intermittent theta burst stimulation (iTBS)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst stimulation (iTBS)Other
iTBS is a magnetic stimulation applied using a magnetic coil that is placed on top of the participants head to activate the brain. It consists of three very rapid bursts of electrical pulses at a frequency of 50 Hz (per burst) delivered at a rate of 5 per second for 2 seconds (10 bursts). The burst of pulses will be repeated every 10 seconds for a total duration of about 3 minutes. The stimulation will be applied to activate the brain regions that control upper limb, lower limb or trunk muscles. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours.
Functional electrical stimulation (FES)Other
FES is applied using electrodes that stick to the skin over the muscles or nerves. It will will be applied using an electrical stimulator to produce movements of the hand, leg or the trunk. The stimulation intensity will be determined by gradually increasing strength from 20-100 hertz (hz) until the right amount of movement is obtained. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours.
Transcutaneous spinal cord stimulation (TSCS)Other
TSCS is applied using electrodes that stick to the skin over the spinal cord to activate spinal cord. Mild electrical stimulation will be applied to make sure the nerves on the back are activated (switched on). Different stimulation intensities (strength) will be tested at different frequencies (pulses per second) to determine the best setting for activating the nerves on the back. The stimulus current strength will be adjusted between 0-250 milliamperes (mA) and will remain within the self-reported tolerance limit of each participant. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours.
Sham Intermittent theta burst stimulation (iTBS)Other
Subjects will be fitted with a magnetic coil that is placed on top of the head that does not deliver any stimulation to the brain. Each subject is expected to participate longitudinally at least 9 times over 2 months.Each visit will take approximately 2-3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Upper-limb (arms) target group | Experimental | Quadriplegic individuals with SCI who are primary non-ambulatory (walking) will be in this group for up to 2 months. Receives: Other: Intermittent theta burst stimulation (iTBS); Other: Functional electrical stimulation (FES); Other: Transcutaneous spinal cord stimulation (TSCS); Other: Sham Intermittent theta burst stimulation (iTBS) |
| Lower-limb (legs) target group | Experimental | Quadriplegic or paraplegic individuals with SCI primary who can walk will be in this group for up to 2 months. Receives: Other: Intermittent theta burst stimulation (iTBS); Other: Functional electrical stimulation (FES); Other: Transcutaneous spinal cord stimulation (TSCS); Other: Sham Intermittent theta burst stimulation (iTBS) |
| Trunk (torso) target group | Experimental | Quadriplegic or paraplegic individuals with SCI who are primary wheelchair users will be in this group for up to 2 months. Receives: Other: Intermittent theta burst stimulation (iTBS); Other: Functional electrical stimulation (FES); Other: Transcutaneous spinal cord stimulation (TSCS); Other: Sham Intermittent theta burst stimulation (iTBS) |
| Able-bodied target group | Active comparator | Individuals with no spinal cord injury will be in this group for up to 2 months. Receives: Other: Intermittent theta burst stimulation (iTBS); Other: Functional electrical stimulation (FES); Other: Transcutaneous spinal cord stimulation (TSCS); Other: Sham Intermittent theta burst stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nine-hole peg test
The Nine-Hole Peg Test assesses hand and finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the activity, recorded in seconds.
Measured: baseline, up to 2 months
Change in foot tapping test (FTT)
FTT assesses motor neuron function and mobility. Participants are seated with the foot on the floor and are asked to tap their foot on the ground as rapidly as possible for 10 seconds while keeping the heel on the ground. The number of taps are counted during the 10 seconds.
Measured: baseline, up to 2 months
Change in Function in Sitting Test for people with SCI (FIST-SCI)
FIST-SCI is a clinical test that will be used to test seated balance. FIST-SCI consists of 14 functional, everyday activities as test items. The items are scored on a 5 point ordinal scale ranging from 0 to 4, with 0 representing the lowest ability and 4 representing normal ability.
Measured: baseline, up to 2 months
Change in Motor Evoked Potential (MEP)
MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).
Measured: baseline, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start4 Nov 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matija Milosevic, University of Miami
- Investigators
- Matija Milosevic, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494059
- Sponsor's protocol ID
- 20240454
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT06494059
- Acronym / sponsor ID
- 20240454
- Conditions
- SCI - Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Upper-limb (arms) target group | Experimental | Other: Intermittent theta burst stimulation (iTBS), Other: Functional electrical stimulation (FES), Other: Transcutaneous spinal cord stimulation (TSCS), Other: Sham Intermittent theta burst stimulation (iTBS)Quadriplegic individuals with SCI who are primary non-ambulatory (walking) will be in this group for up to 2 months. |
| Lower-limb (legs) target group | Experimental | Other: Intermittent theta burst stimulation (iTBS), Other: Functional electrical stimulation (FES), Other: Transcutaneous spinal cord stimulation (TSCS), Other: Sham Intermittent theta burst stimulation (iTBS)Quadriplegic or paraplegic individuals with SCI primary who can walk will be in this group for up to 2 months. |
| Trunk (torso) target group | Experimental | Other: Intermittent theta burst stimulation (iTBS), Other: Functional electrical stimulation (FES), Other: Transcutaneous spinal cord stimulation (TSCS), Other: Sham Intermittent theta burst stimulation (iTBS)Quadriplegic or paraplegic individuals with SCI who are primary wheelchair users will be in this group for up to 2 months. |
| Able-bodied target group | Active comparator | Other: Intermittent theta burst stimulation (iTBS), Other: Functional electrical stimulation (FES), Other: Transcutaneous spinal cord stimulation (TSCS), Other: Sham Intermittent theta burst stimulation (iTBS)Individuals with no spinal cord injury will be in this group for up to 2 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or Female subjects
- At least 18 years old and no older than 70 years old at the time of enrollment.
- Able-bodied subjects
- Traumatic spinal cord injury
- Upper limb target: neurological level at or above Thoracic 1 level, Abbreviated Injury Scale (AIS) B, C or D impairment grade, primary non-ambulatory;
Key exclusion criteria (17 listed)
- Has traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
- Has severe spasticity that could prevent the study protocol as determined by the investigator.
- Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
- Has contraindications for transcutaneous stimulation using FES or TSCS such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease.
- Has a poorly managed autonomic dysreflexia that could be triggered by transcranial magnetic stimulation (TMS), FES, or TSCS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent theta burst stimulation (iTBS)iTBS is a magnetic stimulation applied using a magnetic coil that is placed on top of the participants head to activate the brain. It consists of three very rapid bursts of electrical pulses at a frequency of 50 Hz (per burst) delivered at a rate of 5 per second for 2 seconds (10 bursts). The burst of pulses will be repeated every 10 seconds for a total duration of about 3 minutes. The stimulation will be applied to activate the brain regions that control upper limb, lower limb or trunk muscles. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours. | Other | Able-bodied target group, Lower-limb (legs) target group, Trunk (torso) target group, Upper-limb (arms) target group |
| Functional electrical stimulation (FES)FES is applied using electrodes that stick to the skin over the muscles or nerves. It will will be applied using an electrical stimulator to produce movements of the hand, leg or the trunk. The stimulation intensity will be determined by gradually increasing strength from 20-100 hertz (hz) until the right amount of movement is obtained. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours. | Other | Able-bodied target group, Lower-limb (legs) target group, Trunk (torso) target group, Upper-limb (arms) target group |
| Transcutaneous spinal cord stimulation (TSCS)TSCS is applied using electrodes that stick to the skin over the spinal cord to activate spinal cord. Mild electrical stimulation will be applied to make sure the nerves on the back are activated (switched on). Different stimulation intensities (strength) will be tested at different frequencies (pulses per second) to determine the best setting for activating the nerves on the back. The stimulus current strength will be adjusted between 0-250 milliamperes (mA) and will remain within the self-reported tolerance limit of each participant. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours. | Other | Able-bodied target group, Lower-limb (legs) target group, Trunk (torso) target group, Upper-limb (arms) target group |
| Sham Intermittent theta burst stimulation (iTBS)Subjects will be fitted with a magnetic coil that is placed on top of the head that does not deliver any stimulation to the brain. Each subject is expected to participate longitudinally at least 9 times over 2 months.Each visit will take approximately 2-3 hours. | Other | Able-bodied target group, Lower-limb (legs) target group, Trunk (torso) target group, Upper-limb (arms) target group |
Primary outcome
Change in nine-hole peg test
Time frame: baseline, up to 2 months
The Nine-Hole Peg Test assesses hand and finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Scores are based on the time taken to complete the activity, recorded in seconds.
Change in foot tapping test (FTT)
Time frame: baseline, up to 2 months
FTT assesses motor neuron function and mobility. Participants are seated with the foot on the floor and are asked to tap their foot on the ground as rapidly as possible for 10 seconds while keeping the heel on the ground. The number of taps are counted during the 10 seconds.
Change in Function in Sitting Test for people with SCI (FIST-SCI)
Time frame: baseline, up to 2 months
FIST-SCI is a clinical test that will be used to test seated balance. FIST-SCI consists of 14 functional, everyday activities as test items. The items are scored on a 5 point ordinal scale ranging from 0 to 4, with 0 representing the lowest ability and 4 representing normal ability.
Change in Motor Evoked Potential (MEP)
Time frame: baseline, up to 2 months
MEP evaluates corticospinal excitability (strength of the connections between the brain and the muscles). The excitability is measured as a peak-to-peak amplitude in millivolts (mV).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matija Milosevic, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta burst stimulation (iTBS), Functional electrical stimulation (FES) and Transcutaneous spinal cord stimulation (TSCS) in people with SCI - Spinal Cord Injury, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deena Cilien, DPT ((305) 243-9301, dcilien@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nine-hole peg test (time frame: baseline, up to 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.