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Deep Brain Stimulation for Walking After Spinal Cord Injury

This study is looking at Deep Brain Stimulation (DBS) as a possible way to help people walk better after a spinal cord injury (SCI). DBS involves a device that sends electrical currents to a specific area of the brain called the cuneiform nucleus (CnF). Researchers want to see if this treatment is safe and effective for people with incomplete SCI who have trouble walking. You might be able to join if you are between 22 and 70 years old and had your SCI at least one year ago. The study will measure success by looking at changes in walking speed and how far you can walk over a certain time. The current status of this study is unclear, and it plans to enroll 6 participants.

Study design
This is an interventional study with a planned enrollment of 6 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo a single surgery to implant the DBS device, followed by training sessions three times a week, both before and after the surgery, each lasting up to 60 minutes.
Compensation
Not stated in the trial record.
Follow-up
Your walking ability will be measured at the beginning of the study and then again for up to 34 weeks.

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NCT07109804

Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury

Recruiting
NAAges 22–70InterventionalDevice feasibility
University of Miami
~6 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Deep Brain Stimulation (DBS)Deep Brain Stimulation (DBS) Device Implant ProcedureTraining Sessions

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in walking speed measured by 10-meter walk test
Measured over baseline, up to 34 weeks
+1 more outcome measured

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Brian R Noga, PhD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Brian R Noga, Ph.D.
[email protected]
305-243-6155
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male or female subjects between ages of 22-70
At least 1 year post SCI
Confirmed SCI according to SCI clinician according to clinical history and the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) / American Spinal Injury Association (ASIA) criteria as documented in the American Spinal Injury Association Impairment Scale (AIS) on examination. Other disorders of gait will be excluded by history and a neurological examination.
Persons with incomplete injury grades of ASIA C or D who can stand with support and who have some voluntary leg function and a maximum walking capacity of Walking Index for spinal cord injury - level II (WISCI-II) level 9 or less.
Injury level T10 and above.
Ability to stand with moderate body weight support for at least 5 minutes.
Stable medical and physical condition.
Able to commit to training/evaluation sessions over 6 months and for longer periodic follow-up.

Exclusion

Individuals with high-moderate to severe depression -Beck Depression Inventory II (BDI II) ≥ 25).
Individuals with cognitive impairment indicated by a score of less than 24 on the Folstein Mini-Mental State Examination 2nd ed. (MMSE).
Individuals with alcohol use disorder. The Alcohol Use Disorder Identification Test (AUDIT) will be used to measure harmful patterns of alcohol consumption over the past year. A cutoff score of 8 will be used to identify and exclude those with moderate to severe alcohol use behavior.
Individuals with substance abuse. The Drug Abuse Screening Test (DAST-10) will be used to identify problematic substance abuse behavior over the past year. A cutoff score of 6 will be used to identify and exclude those with moderate to severe drug use behavior.
The presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy as defined by past medical history and abnormal lab work at the investigator/surgeon's discretion.
Individuals with a Berg Balance score \< 21.
Individuals with a history of traumatic brain injury (TBI), seizures, severe autonomic dysreflexia, dysphagia or osteoporosis.
History of prior intracranial surgery or known lesions.
Individuals that require diathermy, repetitive transcranial magnetic stimulation, electroconvulsive therapy, or serial brain MRIs.
Individuals with non-MRI compatible metallic implants in their head or body, and with metallic implants and other implantable devices in the body that could be affected by DBS.
Individuals with active implantable devices anywhere in the body (e.g., cardiac pacemaker, defibrillator, implanted medication pump).
Individuals who are pregnant desire to become pregnant during the study.
Individuals who are breastfeeding.
Individuals with intractable orthostatic hypotension despite treatment.
Individuals with a recent history of limb fracture, ligamentous injury, active pressure sores or unstable skin structures (e.g., skin grafts and chest tubes).

What this trial measures

  • Change in walking speed measured by 10-meter walk testbaseline, up to 34 weeks

    The ten-meter walk test will be measured in meters/second.

  • Change in distance measured by 6-min walk testbaseline, up to 34 weeks

    The 6-min walk test will be measured in meters