Non-invasive Brain and Spinal Cord Stimulation for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with chronic cervical spinal cord injury who struggle with arm and hand function. It combines two non-invasive techniques: cerebellar theta burst stimulation (a type of brain stimulation) and cervical transcutaneous spinal cord stimulation (a type of spinal cord stimulation). The researchers aim to determine if this combination can enhance the ability to perform tasks like pinching and grasping. Individuals with a stable cervical spinal cord injury for at least 12 months who face ongoing challenges with their upper limbs may be suitable candidates. Participants will receive one of three treatments over an 8-week period: both stimulations, only the spinal cord stimulation, or a sham (placebo) version. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for spinal cord injuries.
Will I have to stop taking my current medications?
The trial requires that if you are taking anti-spasticity or pain medications, you must be on a stable dose for at least 4 weeks before starting the study. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What prior data suggests that this non-invasive brain and spinal cord stimulation is safe for spinal cord injury?
Research has shown that cerebellar theta burst stimulation (TBS) is generally safe and well-tolerated. Several studies have found no serious side effects linked to cerebellar TBS. It works quickly, using shorter sessions to create lasting changes in brain activity. However, as a newer method, experts recommend cautious use.
For cervical transcutaneous spinal cord stimulation (tSCS), research indicates it is safe and effective, particularly for adults with long-term spinal cord injuries. Studies have not reported any serious issues like permanent nerve damage or infections. Some mild or temporary side effects might occur, but they are not serious.
Both treatments are non-invasive, meaning they do not involve surgery. Devices outside the body stimulate the brain and spinal cord. Overall, studies suggest these treatments are safe, although ongoing research aims to fully understand their potential and safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about non-invasive brain and spinal cord stimulation for spinal cord injury because it offers a unique approach compared to traditional treatments like surgery, physical therapy, and medications. Unlike these standard methods, cerebellar theta burst stimulation (TBS) and cervical transcutaneous spinal cord stimulation (tSCS) aim to enhance neural plasticity and improve motor function by directly stimulating the nervous system without the need for invasive procedures. This technique could potentially accelerate recovery and improve outcomes for individuals with spinal cord injuries by harnessing the brain and spinal cord’s natural ability to adapt and reorganize. Additionally, the use of sham stimulation in the trial helps to rigorously assess the effectiveness of these methods, which increases confidence in the results.
What evidence suggests that this trial's treatments could be effective for spinal cord injury?
This trial will evaluate the effects of cerebellar theta burst stimulation (TBS) and cervical transcutaneous spinal cord stimulation (tSCS) on spinal cord injury recovery. Research has shown that cerebellar TBS can aid in the recovery of motor skills, such as walking, after a stroke. Meanwhile, tSCS shows promise for enhancing movement in individuals with spinal cord injuries, with studies finding that it can quickly improve hand movement and muscle activity. In this trial, some participants will receive both cerebellar TBS and cervical tSCS, while others will receive only cervical tSCS. Both treatments aim to improve communication between the brain and spinal cord, which is crucial for regaining control of movement. Together, they might offer a new way to enhance arm and hand function in people with spinal cord injuries.23678
Are You a Good Fit for This Trial?
This trial is for adults aged 19-75 with a non-progressive cervical spinal cord injury (C2-C8) that happened at least a year ago. Participants must have some arm/hand function, be medically stable, able to consent, and on stable medication if needed.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cerebellar TBS + cervical tSCS, tSCS only, or sham stimulation while engaging in functional task practice such as pinching and grasping 3x/week for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cerebellar theta burst stimulation
- Cervical transcutaneous spinal cord stimulation
- Functional task practice
Trial Overview
The study tests whether combining two types of non-invasive stimulation—cerebellar theta burst (brain) and cervical transcutaneous spinal cord stimulation—improves arm and hand function after chronic spinal cord injury. Some participants get both stimulations, some only one, or sham treatment while practicing tasks.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
Participants will recieve 60 min of active cervical transcutaneous spinal cord stimulation with intermittent bouts of active Cerebellar theta burst stimulation 3x/week for 8 weeks, alongside functional task practice.
Participant will recieve 60 min of active cervical transcutaneous spinal cord stimulation only 3x/week for 8 weeks, alongside functional task practice.
Participants will recieve 60 min of sham cervical transcutaneous spinal cord stimulation with intermittent bouts of sham Cerebellar theta burst stimulation 3x/week for 8 weeks, alongside functional task practice.
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Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Citations
The effectiveness of theta burst stimulation for motor recovery ...
This paper provides a comprehensive overview and assessment of the current impact of TBS on motor rehabilitation following stroke
CEREBRAL THETA-BURST STIMULATION COMBINED WITH ...
Nine weeks of cerebral intermittent thetaburst stimulation with physiotherapy intervention resulted in improved recovery of lower extremity motor recovery.
Safety Considerations for Cerebellar Theta Burst Stimulation
No serious adverse events have been reported for cerebellar TBS. There is no substantial evidence of a tolerable maximal-efficacy stimulation dose in humans.
Cerebellar Theta Burst Stimulation on Walking Function in ...
The objective of this study was to explore the efficacy of cerebellar intermittent theta burst stimulation (iTBS) on the walking function of stroke patients.
Study Details | NCT02526238 | Effectiveness of Theta Burst ...
This is a double blinded, randomized control trial with a pretest-posttest control and interventional group design. The assessor is blinded to all ...
Safety Considerations for Cerebellar Theta Burst Stimulation
Theta burst stimulation (TBS) is an efficient and powerful TMS protocol that is able to induce longer-lasting effects with shorter stimulation times compared ...
Safety of Theta Burst Transcranial Magnetic Stimulation - PMC
Based on this review, TBS appears to be a safe and efficacious technique. However, given its novelty, it should be applied with caution.
Cerebellar Intermittent Theta-Burst Stimulation and Motor ...
Outcome measures included dystonia severity and pain, quality of life, hand dexterity, and motor-evoked potentials and cortical silent periods recorded from ...
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