NCT06826274Not yet recruitingNot Applicable
Clinical and Neurophysiological Evaluation of the Effects of Cervical TsDCS on Stroke Patients with Distal Upper Limb Strength Deficit
IRCCS San Raffaele Roma1 site in 1 country40 target enrollmentStarted: March 1, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- improvement of paretic hand performance
Study Overview
Brief Summary
The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Group Stroke:
- •Inclusion criteria:
- •age over 18 years;
- •first ischemic/hemorrhagic stroke (within 30 days of onset);
- •mild-to-moderate stroke (NIHSS scale score<16).
- •residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;
- •ability to give informed consent and understand instructions.
Exclusion Criteria
- •severe spasticity (Ashworth Scale score > 2);
- •severe aphasia;
- •severe neglect;
- •history of disabling neurological disease;
- •history of epilepsy;
- •significant comorbidities;
- •contraindications to tsDCS.
- •Healthy Group:
- •Inclusion criteria:
- •age over 18 years;
- •equalized in age with the patient group.
- •Exclusion criteria:
- •history of stroke progress;
- •history of severe neurological disease.
Arms & Interventions
Healthy
Experimental
Intervention: tDCS (Other)
Stroke
Experimental
Intervention: tDCS (Other)
Outcomes
Primary Outcomes
improvement of paretic hand performance
Time Frame: through study completion, an average of 1 year
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Reaching
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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