Cervical tsDCS on Stroke Patients (AMPLI-MOV)

November 3, 2026 updated by: IRCCS San Raffaele Roma

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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
through study completion, an average of 1 year
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 Grasping
through study completion, an average of 1 year
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 Lifting test
through study completion, an average of 1 year
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 duringthe Nine Hole Peg test
through study completion, an average of 1 year
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 finger mobility tests
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

February 13, 2025

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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