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NCT Number: NCT06826274

Cervical TsDCS on Stroke Patients

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.

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Key information

Conditions

Functional Recovery Motor Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tDCS

Other

Transcranial direct current stimulation

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrizio Vecchio

CONTACT

[email protected]

3478031201

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study title

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

Acronym: AMPLI-MOV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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