Brain Stimulation + Motor Training for Spinal Cord Injury
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
No Placebo Group
Trial Summary
What is the purpose of this trial?The overall goals of this proposal are to examine the contribution of physiological pathways to the control of grasping behaviors after cervical SCI, and to maximize the recovery of grasping by using tailored non-invasive brain stimulation and acoustic startle protocols with motor training. The investigators propose to study two basic grasping behaviors, which are largely used in most daily-life activities: a precision grip and a power grip.
How does the treatment of brain stimulation and motor training for spinal cord injury differ from other treatments?
This treatment combines brain stimulation, specifically intermittent theta burst stimulation (iTBS), with motor training to enhance neural plasticity and motor function in spinal cord injury patients. Unlike traditional therapies, iTBS aims to alter corticospinal excitability, potentially leading to improved motor recovery by promoting short-term and possibly long-term changes in neural output.
23456What data supports the effectiveness of the treatment iTMS, Transcranial Magnetic Stimulation, Intermittent Theta-Burst Stimulation, Sham iTMS, Sham Interleaved Transcranial Magnetic Stimulation, Sham iTMS for spinal cord injury?
Research shows that intermittent theta-burst stimulation (iTBS), a type of brain stimulation, can create short-term changes in nerve activity in people with spinal cord injuries, which might help improve movement. In animal studies, repeated iTBS sessions increased nerve growth and motor function, suggesting potential benefits for recovery.
23456Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking drugs that affect the central nervous system and lower the seizure threshold.
Eligibility Criteria
This trial is for right-handed adults aged 18-85, both healthy and those with chronic spinal cord injury (SCI) at C8 or above. Healthy participants must be able to grip and move their wrists. SCI participants need some wrist movement and the ability to grip, but can't join if they have uncontrolled medical issues, a history of severe mental health problems, head injury or stroke, pacemakers, metal in the skull, seizure history, certain medications lowering seizure threshold or are pregnant.Exclusion Criteria
I do not have uncontrolled health issues or a history of major mental health, head injury, stroke, seizures, or specific spinal cord diseases.
Participant Groups
The study tests how brain stimulation (iTMS) combined with motor tasks affects grasping function after cervical SCI. Participants will practice precision and power grips while receiving either real iTMS or a sham treatment without actual stimulation. The goal is to see if this combination improves hand function.
3Treatment groups
Active Control
Group I: Experiment 1bActive Control2 Interventions
To accomplish this aim the investigators propose to complete one main experiment. The investigators will use iTMS and/or an acoustic startle stimuli to test the hypothesis that induced-plasticity protocols (iTMS and startle stimuli) will enhance EMG and force output in hand muscles during grasping. In a randomized sham crossover design, SCI and controls will be assigned to two groups: (1) iTMS applied during precision and power grip (two randomized sessions), and (2) startle applied during precision and power grip (two randomized sessions).
Group II: Experiment 2Active Control4 Interventions
To accomplish this aim the investigators propose to complete one main experiment. The investigators will combine iTMS and/or acoustic startle with precision and power grip training to test the hypothesis that 'precision and power grip training outcomes will be enhanced by iTMS and startle induced plasticity'. In a randomized sham controlled design, SCI and control subjects will be assigned to: training+iTMS and training+sham iTMS and training+startle and training+sham startle.
Group III: Experiment 1aActive Control2 Interventions
Examine physiological mechanisms contributing to the control of precision and power grip behaviors. To accomplish this aim the investigators propose to complete one main experiment. The investigators will test the hypotheses that there are two fundamentally distinct modes of hand operation after SCI. One involves brainstem pathways, and permits whole-hand 'power grip', while the other involves corticospinal and motor cortical connections, and allows a wide range of fractionated finger movements (precision grip) after SCI. Measurements of corticospinal, reticulospinal, and motoneuron excitability will be tested during index finger abduction, precision and power grip.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Edward Hines Jr. VA Hospital, Hines, ILHines, IL
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
References
Effects of intermittent theta burst stimulation on spasticity after spinal cord injury. [2019]Spasticity is a common disorder in patients with spinal cord injury (SCI). The aim of this study was to investigate whether intermittent theta burst stimulation (iTBS), a safe, non-invasive and well-tolerated protocol of excitatory repetitive transcranial magnetic stimulation (rTMS), is effective in modulating spasticity in SCI patients.
Transcranial Magnetic Stimulation with Intermittent Theta Burst Stimulation Alters Corticospinal Output in Patients with Chronic Incomplete Spinal Cord Injury. [2020]Intermittent theta burst stimulation (iTBS) is intended primarily to alter corticospinal excitability, creating an attractive opportunity to alter neural output following incomplete spinal cord injury (SCI). This study is the first to assess the effects of iTBS in SCI. Eight individuals with chronic incomplete SCI were studied. Sham or real iTBS was delivered (to each participant) over primary motor and somatosensory cortices in separate sessions. Motor-evoked potential (MEP) recruitment curves were obtained from the flexor carpi radialis muscle before and after iTBS. Results indicate similar responses for iTBS to both motor and somatosensory cortex and reduced MEPs in 56.25% and increased MEPs in 25% of instances. Sham stimulation exceeded real iTBS effects in the remaining 18.25%. It is our opinion that observing short-term neuroplasticity in corticospinal output in chronic SCI is an important advance and should be tested in future studies as an opportunity to improve function in this population. We emphasize the need to re-consider the importance of the direction of MEP change following a single session of iTBS since the relationship between MEP direction and motor function is unknown and multiple sessions of iTBS may yield very different directional results. Furthermore, we highlight the importance of including sham control in the experimental design. The fundamental point from this pilot research is that a single session of iTBS is often capable of creating short-term change in SCI. Future sham-controlled randomized trials may consider repeat iTBS sessions to promote long-term changes in corticospinal excitability.
Intermittent theta-burst stimulation for upper-limb dysfunction and spasticity in spinal cord injury: a single-blind randomized feasibility study. [2018]Single-blind, sham-controlled, crossover randomized feasibility study OBJECTIVES: (1) Assess the feasibility of a full-scale trial of intermittent theta-burst stimulation (iTBS) for upper-limb sensorimotor dysfunction following spinal cord injury (SCI). (2) Determine the safety and tolerability of iTBS over primary motor cortex on upper-limb function in people with spinal cord injury (SCI).
Neuromodulatory effects of repetitive transcranial magnetic stimulation on neural plasticity and motor functions in rats with an incomplete spinal cord injury: A preliminary study. [2021]We investigated the effects of intermittent theta-burst stimulation (iTBS) on locomotor function, motor plasticity, and axonal regeneration in an animal model of incomplete spinal cord injury (SCI). Aneurysm clips with different compression forces were applied extradurally around the spinal cord at T10. Motor plasticity was evaluated by examining the motor evoked potentials (MEPs). Long-term iTBS treatment was given at the post-SCI 5th week and continued for 2 weeks (5 consecutive days/week). Time-course changes in locomotor function and the axonal regeneration level were measured by the Basso Beattie Bresnahan (BBB) scale, and growth-associated protein (GAP)-43 expression was detected in brain and spinal cord tissues. iTBS-induced potentiation was reduced at post-1-week SCI lesion and had recovered by 4 weeks post-SCI lesion, except in the severe group. Multiple sessions of iTBS treatment enhanced the motor plasticity in all SCI rats. The locomotor function revealed no significant changes between pre- and post-iTBS treatment in SCI rats. The GAP-43 expression level in the spinal cord increased following 2 weeks of iTBS treatment compared to the sham-treatment group. This preclinical model may provide a translational platform to further investigate therapeutic mechanisms of transcranial magnetic stimulation and enhance the possibility of the potential use of TMS with the iTBS scheme for treating SCIs.
Intermittent theta burst stimulation modulates biceps brachii corticomotor excitability in individuals with tetraplegia. [2023]Intermittent theta burst stimulation (iTBS) is a form of repetitive transcranial magnetic stimulation (TMS) that can increase corticomotor excitability of hand muscles in individuals with spinal cord injury (SCI). The objective of this study was to determine the effect of iTBS on the corticomotor excitability of the biceps brachii in individuals with tetraplegia.
Cerebral Theta-Burst Stimulation Combined with Physiotherapy in Patients with Incomplete Spinal Cord Injury: A Pilot Randomized Controlled Trial. [2023]To measure the effects of cerebral intermittent theta-burst stimulation with physiotherapy on lower extremity motor recovery in patients with incomplete spinal cord injury.