Targeted HD-tDCS to Improve Upper Limb Rehabilitation in SCI (NCT05589415) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Targeted HD-tDCS to Improve Upper Limb Rehabilitation in SCI
United States24 participantsStarted 2020-11-23
Plain-language summary
The proposed project seeks to maximize the functional recovery achieved during the rehabilitation of the paretic upper limbs in individuals with SCI. The investigation will work towards optimizing the use of transcranial direct current stimulation (tDCS), an adjunct known to improve the effectiveness of rehabilitation. In particular, the relationship between the specificity of current delivery and functional benefit will be explored, and findings may lead to a framework that can be translated to the clinic setting.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Age between 18 and 75 years
* Physician diagnosed cervical incomplete spinal cord injury or lesion (iSCI)
* Classified by the American Spinal Cord Association (AIS) impairment scale as AIS C or D
* iSCI occurred at least 18 months ago
* Level of injury or lesion is between C2 and T1
* Bicep strength must be classified as ≥ 3 muscle grade as defined by the medical research council (MRC) scale
* Tricep strength must be at least an MRC grade of 2 and be at least 1 muscle grade lower than bicep
* Both the biceps and triceps will be required to elicit an active motor evoked potential \>200 uV with transcranial magnetic stimulation
* Must maintain current medication regime
* Must present with a weaker side of the body, as indicated by a Upper Extremity Motor Score (UEMS) score difference between the left and right side
* UEMS \< 40 (50 max score)
Exclusion Criteria:
* Pacemaker or other implanted device
* Metal in the skull
* History of seizures
* Pregnancy
* First-degree relative with medication-resistant epilepsy
* Current participation in upper limb rehabilitation therapies
* Current use of illicit drugs, abusing alcohol, or have withdrawn from alcohol in the last 6 months
* Other neurological impairment or condition
* Pressure ulcers
* Significant lower motor neuron loss at C7 as noted by a nerve c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)
Timeframe: Collected four times during study duration: (Baseline-phase) Day 1 and 14; (Post-Rehabilitation-phase) Day 1 and 14
2
Excitability of weak muscle pathways
Timeframe: Collected four times during study duration: (Baseline-phase) Day 1 and 14; (Post-Rehabilitation-phase) Day 1 and 14