NCT06826274

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

January 29, 2025

Last Update Submit

February 12, 2025

Conditions

Functional RecoveryMotor Rehabilitation

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Stroke

EXPERIMENTAL
Other: tDCS

Healthy

EXPERIMENTAL
Other: tDCS

Interventions

tDCSOTHER

Transcranial direct current stimulation

HealthyStroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • age over 18 years;
  • equalized in age with the patient group.
  • history of stroke progress;
  • history of severe neurological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Roma

Rome, Rome, 00163, Italy

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Fabrizio Vecchio

CONTACT

3478031201fabrizio.vecchio@sanraffaele.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 13, 2025

Study Start

March 1, 2025

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

IT(1)