Cervical TsDCS on Stroke Patients (AMPLI-MOV)

IRCCS San Raffaele Roma

Status: Not yet enrolling

Conditions: Motor Rehabilitation; Functional Recovery

Treatments: Other: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06826274

RP 23/06

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Group Stroke:

Inclusion criteria:

1. age over 18 years;
2. first ischemic/hemorrhagic stroke (within 30 days of onset);
3. mild-to-moderate stroke (NIHSS scale score<16).
4. 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;
5. ability to give informed consent and understand instructions.

Exclusion criteria:

1. severe spasticity (Ashworth Scale score > 2);
2. severe aphasia;
3. severe neglect;
4. history of disabling neurological disease;
5. history of epilepsy;
6. significant comorbidities;
7. contraindications to tsDCS.

Healthy Group:

Inclusion criteria:

1. age over 18 years;
2. equalized in age with the patient group.

Exclusion criteria:

1. history of stroke progress;
2. history of severe neurological disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Stroke

Experimental group

Treatment:

Other: tDCS

Healthy

Experimental group

Treatment:

Other: tDCS