Efficacy of Cerebello-spinal Direct Current Stimulation (csDCS) on Functional Mobility in Chronic Stroke Patients

Universidade Federal de Pernambuco

Status and phase: Enrolling; Phase 2

Conditions: Gait Disorders, Neurologic; Stroke Rehabilitation; tDCS

Treatments: Device: Sham Comparator; Device: Cerebello-spinal direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07073287

csDCS_Stroke_Mobility

Details and patient eligibility

About

The aim of this clinical trial is to determine if cerebello-spinal direct current stimulation (csDCS) is effective in treating gait disorders in individuals with chronic stroke. Additionally, the trial seeks to evaluate the safety of this technique.

The primary objectives include:

Investigating whether cerebello-spinal direct current stimulation improves gait and functional mobility in participants with chronic stroke.

Assessing any potential side effects associated with the method.

Researchers will conduct a comparative analysis between cerebello-spinal direct current stimulation and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness in addressing gait disorders and enhancing mobility.

Participants in the trial will:

Undergo cerebello-spinal direct current stimulation combined with treadmill training or a sham procedure with treadmill training daily over a two-week period.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmation of Stroke by digital or physical imaging or medical report
• Gait impairment
• Stroke with at least 6 months after ictus

Exclusion criteria

• Metallic implants in spinal cord
• Major orthopedic/rheumatological disorders
• Inability of verbal or non-verbal communication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Active cerebello-spinal direct current stimulation

Experimental group

Description:

csDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.

Treatment:

Device: Cerebello-spinal direct current stimulation

Sham cerebello-spinal direct current stimulation

Sham Comparator group

Description:

Treadmill training with masking for cerebello-spinal direct current stimulation

Treatment:

Device: Sham Comparator