54 Participants NeededMy employer runs this trial

Neuromodulation for Spinal Cord Injury

HJ
Overseen ByHang Jin Jo, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: State University of New York at Buffalo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with spinal cord injuries improve hand function. Researchers are testing a noninvasive brain stimulation technique called Intermittent Theta Burst Stimulation, combined with hand exercises, to determine if it can enhance nerve signals and improve hand movement. Participants will receive either real or sham (placebo) treatments to compare their effects. Individuals who have had a cervical spinal cord injury for at least a year and can still activate certain hand muscles might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation options for spinal cord injuries.

Will I have to stop taking my current medications?

The trial excludes people taking drugs that affect the central nervous system and lower the seizure threshold, like antipsychotic drugs. If you're on such medications, you might need to stop them to participate.

What prior data suggests that this neuromodulation technique is safe for improving hand function in spinal cord injury patients?

Research has shown that Intermittent Theta Burst Stimulation (iTBS) is generally safe for people with spinal cord injuries. Studies have found that iTBS can improve movement and reduce muscle tightness (spasticity) without causing major side effects. Specifically, patients who received real iTBS reported better movement in their lower limbs and less muscle tightness compared to those who received a placebo treatment.

Similarly, Paired Corticospinal Motoneuronal Stimulation (PCMS) has been tested for safety in people with long-term spinal cord injuries. Research suggests that PCMS can safely enhance voluntary movement by strengthening the connections between the brain and spinal cord. These studies reported no major negative side effects.

Both treatments have shown promise in improving function without major safety concerns in previous research. However, as with any treatment, individual experiences may vary, and discussing potential risks with a healthcare provider is important.12345

Why are researchers excited about this trial?

Researchers are excited about the neuromodulation techniques being tested for spinal cord injury because they represent a shift from traditional rehabilitation approaches like physical therapy and medication. Intermittent Theta Burst Stimulation (iTBS) and Paired Corticospinal Motoneuronal Stimulation (PCMS) aim to enhance neural plasticity, potentially leading to better recovery of movement and function. Unlike conventional treatments, these techniques target the nervous system directly to promote the repair and strengthening of neural connections. By potentially accelerating the recovery process and improving outcomes, these methods could offer a significant advantage over existing options.

What evidence suggests that this trial's treatments could be effective for improving hand function in cervical spinal cord injury?

Research has shown that intermittent theta burst stimulation (iTBS) can aid people with spinal cord injuries by enhancing movement and reducing muscle tightness. Studies have found that iTBS can ease arm use and lessen muscle stiffness after an injury. In this trial, participants may receive both iTBS and paired corticospinal motoneuronal stimulation (PCMS). PCMS has improved abilities like walking and gripping, with benefits lasting several months. It enhances signals between the brain and muscles, aiding better movement control. Together, these treatments offer hope for improving hand function in people with spinal cord injuries.12678

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with a chronic spinal cord injury at the neck level (C8 or above) for at least one year, who have some hand muscle response. People can't join if they are pregnant, have uncontrolled health issues, certain mental illnesses, history of seizures or head injuries, metal in their skull, or take specific brain-affecting drugs.

Inclusion Criteria

Individuals who have MEP responses in at least one FDI muscle
For individuals with SCI:
I am between 18 and 75 years old.
See 2 more

Exclusion Criteria

Pregnant females
I do not have any uncontrolled heart or lung problems.
History of seizures
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either active or sham iTBS and PCMS with or without exercise for 10 sessions

4 weeks
10 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Intermittent Theta Burst Stimulation
  • Paired Corticospinal Motoneuronal Stimulation

Trial Overview

The study tests whether noninvasive brain and nerve stimulation techniques (like iTBS and PCMS), alone or combined with exercise training, can improve hand function after spinal cord injury. Some participants will receive real stimulation while others get sham (inactive) treatments for comparison.

How Is the Trial Designed?

4

Treatment groups

Active Control

Placebo Group

Group I: iTBS and PCMSActive Control2 Interventions
Group II: iTBS and PCMS with exerciseActive Control3 Interventions
Group III: Sham iTBS and PCMSPlacebo Group2 Interventions
Group IV: Sham iTBS and sham PCMS with exercisePlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41651329/

Effects of Intermittent Theta Burst Stimulation on Motor, Gait ...

Conclusions: iTBS may offer beneficial effects on lower-limb motor function, step length, pain, functional independence, and spasticity in ...

Effect of Intermittent Theta Burst Stimulation Dual-Target ...

ITBS dual-target stimulation can significantly improve the motor function of both lower limbs in patients with iSCI but does not significantly improve the ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29895874/

Intermittent theta-burst stimulation for upper-limb ...

A full-scale trial of intermittent theta-burst stimulation (iTBS) for upper-limb sensorimotor dysfunction following spinal cord injury (SCI).

Effects of Intermittent Theta Burst Stimulation on Motor, Gait ...

Transcranial magnetic stimulation with intermittent theta burst stimulation alters corticospinal output in patients with chronic incomplete spinal cord injury.

Intermittent Theta Burst Stimulation and Repetitive ...

iTBS lasts shorter than rTMS so that this technique comfortable than rTMS for both patients and also physicians. Aim of this study is to compare ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40577046/

Corticospinal Intermittent Theta Burst Stimulation ...

This study aims to assess the effect of iTBS on corticospinal tract integrity, plasticity, and regaining of motor and sensory function in patients with cSCI.

Effects of Intermittent Theta Burst Stimulation on Motor, Gait ...

Compared with sham iTBS, iTBS showed significant improvements in Lower Extremity Motor Score (LEMS) (mean difference [MD]: 7.13, 95% confidence ...

Corticospinal Intermittent Theta Burst Stimulation ...

This study aims to assess the effect of iTBS on corticospinal tract integrity, plasticity, and regaining of motor and sensory function in patients with cSCI.