Double stimulation may restore arm movement in spinal cord injury
NCT ID NCT07586644
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether combining two types of non-invasive stimulation—one on the brain and one on the spine—can improve arm and hand function in people with chronic incomplete cervical spinal cord injury. 24 adults will receive either both stimulations plus rehabilitation, or spinal stimulation plus rehabilitation alone, over 12 weeks. The goal is to see if the combined approach leads to better motor recovery and to gather data for a larger future trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Chronicity: More than 12 months post-injury at enrollment * Injury type: Traumatic or non-traumatic incomplete cervical SCI, neurological level C2 to C8 * AIS classification: Grade C or D * UEMS: 10 to 20 out of 25 on the more impaired side; lower bound 10 ensures sufficient voluntary activation for task training and elicitable MEPs, upper bound avoids ceiling effects. * Grip strength: MMT grade 3 or higher in finger flexors (C8 myotome) on at least one side. * Hand function: Able to transfer at least 1 block across the partition within 60 seconds on the more impaired side. * Sitting tolerance: Able to tolerate upright seated posture in own wheelchair for at least 1 continuous hour without symptomatic orthostatic hypotension or pressure-related discomfort requiring position change. * Medical stability: No acute medical complications * Informed consent: Able to provide written informed consent and comply with the study schedule * Medications: Stable regimen for 4 weeks prior, AND participant plus clinician agreement that dosage (baclofen, tizanidine, botulinum toxin) remains unchanged throughout the 12-week intervention; any change logged as protocol deviation * Surgical clearance: Cleared by neurosurgeon or orthopedic surgeon for participation in tSCS-based rehabilitation Exclusion Criteria: * Seizure history: History of seizures or epilepsy * Implanted devices: Intracranial metallic implants, cochlear implants, cardiac pacemakers, or other implanted electronic devices. Cervical spinal instrumentation (e.g., posterior rods, plates, or screws at C2 to T1) is not an exclusion for tSCS provided overlying skin is intact; participants with hardware directly beneath planned electrode sites will undergo low-intensity test stimulation during screening, and electrode placement will be shifted by one interspace if current distortion, focal discomfort, or unexpected motor thresholds are observed. Intracranial hardware remains an absolute exclusion for iTBS. * Prior craniotomy: Prior neurosurgical procedure involving craniotomy * Pregnancy: Currently pregnant or intending to become pregnant during the study period * Psychiatric or cognitive: Active psychiatric illness (eg, untreated major depression, psychosis) or cognitive impairment precluding informed consent * Concurrent neurological disease: Progressive or degenerative neurological condition (eg, multiple sclerosis, motor neuron disease) * Concurrent trials: Participation in another interventional rehabilitation or neurostimulation trial * Skin integrity: Skin lesions or breakdown at electrode placement sites (scalp or posterior cervical spine) * Cortical excitability medications: Medications known to alter cortical excitability (eg, antiepileptic drugs, high-dose benzodiazepines) that cannot be stabilized for at least 2 weeks prior to enrollment * Severe spasticity: Modified Tardieu Scale muscle reaction grade 4 (unfatigable clonus \>10 s) at elbow or wrist flexors on the more impaired side, or spasticity judged by the treating physician as unresponsive to optimised pharmacological management.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alexandra Hospital/ National University Hospital
Singapore, Singapore
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Spinal implant aims to restore bladder control after paralysis
- Can virtual walking trick the brain into easing chronic pain?
- Spinal fluid antibody shots tested for fresh spinal cord injuries
- Mind over matter: can a brain implant restore hand control?
- Mind over matter: can a wireless brain implant restore control for the paralyzed?