An interventional study of Intermittent theta burst stimulation in Quadriplegia/Tetraplegia, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Basic science
Among 122 studies in Quadriplegia with a site in United States — 43 open to participants now, 50 under way, 2 of them phase 3. Quadriplegia · United States.
Among the 122 studies in Quadriplegia with a site in United States, this one is the 44th largest by enrollment of the 111 interventional ones that give a count, is one of 8 that started in 2018, is one of 82 with no phase, and was the 55th registered.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
Browse Quadriplegia studies →43 of the 122 studies in Quadriplegia with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18–80
Neuralink Corp · Sites in United States
Ages 18+
Northwell Health · Sites in United States
Ages 21–75
NervGen Pharma · Sites in United States, Canada
Ages 18–75
James J. Peters Veterans Affairs Medical Center · Sites in United States
Ages 22+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 57 Quadriplegia studies recruiting now, 17 (30%) set no upper age limit and 28 (49%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
122 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 14 · Phase 3 7 · Phase 4 4
First in 1989; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 19 is above the median of 15 across 193 interventional studies indexed under Quadriplegia.
Median enrollment 14 across the 111 interventional studies, 34 across the 10 observational. Of the 61 that completed or were terminated, 29 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 122 have an industry lead sponsor. The 10 most frequent:
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Virginia Commonwealth University has 3 studies filed under Quadriplegia — fewer than ten, so there is no comparison to draw.
16 of the studies in Quadriplegia with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07799532Phase 3NervGen PharmaA Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury | 2027-07 |
| NCT07625332Phase 3Northwell HealthPilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI) | 2027-08 |
| NCT05423600Virginia Commonwealth UniversityTransspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia | 2026-11 |
| NCT06295146University of PittsburghVirtual Peer Coaching in Manual Wheelchair Skills | 2026-12-30 |
| NCT05626816MetroHealth Medical CenterAcute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury | 2026-12-31 |
Add all 16 to your calendar (.ics) → With an account.
Among the 122 studies in Quadriplegia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A repetitive, non-invasive brain stimulation technique referred to as theta burst stimulation can modulate corticomotor excitability and therefore has great rehabilitative potential for individuals with neurologic deficits, including individuals with spinal cord injury (SCI). In particular, intermittent theta burst stimulation (iTBS) can increase corticomotor excitability and may be a useful adjunct to physical rehabilitation to promote motor re-education after upper limb reconstruction in individuals with tetraplegia. Upper limb reconstruction involves surgical transfer of a non-paralyzed tendon or nerve with a redundant or less important function to perform a more critical function. Upper limb reconstruction is intended to help individuals achieve their goals related to activities of daily living and independence in the community. Outcomes after reconstruction are variable and depend largely on the efficacy of motor re-education of the transferred muscle to perform a new function. The long-term goal of our research is to determine whether iTBS combined with physical rehabilitation can improve motor re-education after reconstruction. As a first step, the purpose of this proposal is to determine the effect of iTBS on corticomotor excitability of proximal muscles in nonimpaired individuals and two groups of individuals with tetraplegia: individuals with and without upper limb reconstruction.
Inclusion Criteria for all subjects with tetraplegia:
Inclusion criteria for the subjects with tetraplegia and upper limb reconstruction:
Exclusion criteria for all subjects with tetraplegia:
Neurologically normal subjects (i.e., nonimpaired) will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.
Other: Intermittent theta burst stimulation
Individuals with quadriplegia will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.
Other: Intermittent theta burst stimulation
Individuals with quadriplegia and upper limb reconstruction will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.
Other: Intermittent theta burst stimulation
Intermittent theta burst stimulation (iTBS) is a non-invasive brain stimulation technique that can increase corticomotor excitability.
Change in corticomotor excitability
Corticomotor excitability will be measured via motor evoked potential amplitudes in response to transcranial magnetic stimulation
Time frame: Each subject will participate in five sessions, each session separated by 3 days. After each session, changes in corticomotor excitability will be measured. Changes in excitability will be reported through study completion, an average of one month.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Feb 2020, 22 months.
Of 77 non-industry interventional studies with no phase under Quadriplegia, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 309. This study's 22 months is below that.
Counting every sponsor, half of 97 studies reached it within 41 months; a quarter within 15 and three quarters within 309.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Virginia Commonwealth University →