Cervical TsDCS on Stroke Patients (AMPLI-MOV)

Clinical and Neurophysiological Evaluation of the Effects of Cervical TsDCS on Stroke Patients with Distal Upper Limb Strength Deficit

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 Overview

• Status: Not yet recruiting
• Conditions: Functional Recovery; Motor Rehabilitation
• Intervention / Treatment: Other: tDCS

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabrizio Vecchio; Phone Number: 3478031201; Email: fabrizio.vecchio@sanraffaele.it

Study Locations

• Italy
  • Rome, Italy, 00163
    • IRCCS San Raffaele Roma
    • Contact: Fabrizio v; Phone Number: 3478031201; Email: fabrizio.vecchio@sanraffaele.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy	Other: tDCS; Transcranial direct current stimulation
Experimental: Stroke	Other: tDCS; Transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of paretic hand performance	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	through study completion, an average of 1 year
improvement of paretic hand performance	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 Grasping	through study completion, an average of 1 year
improvement of paretic hand performance	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 Lifting test	through study completion, an average of 1 year
improvement of paretic hand performance	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 duringthe Nine Hole Peg test	through study completion, an average of 1 year
improvement of paretic hand performance	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 finger mobility tests	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RP 23/06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No