Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke

Stroke Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01927458
• Other study ID #: M-2012-570-12
• Status: Terminated
• Phase: N/A
• First received: August 15, 2013
• Last updated: February 4, 2017
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal tDCS.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Onset of stroke less than 14 days

• First ischemic stroke causing lower limb weakness (MRC score =4 in knee extensors) and gait impairment

Exclusion Criteria:

• Contraindications to MRI or TMS

• Other neurological disorders

• Significant somatic or psychiatric disorders

• History of seizures

• Language or cognitive disorders prohibiting participation

Related Conditions & MeSH terms

• Neurorehabilitation
• Stroke

Intervention

Device:
• Transcranial Direct Current Stimulation
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue

Locations

Country	Name	City	State
Denmark	Hammel Neurocenter	Hammel

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal gait speed using the 10-m walking test		Baseline and follow up immediately following the 4 weeks intervention
Secondary	Changes in cortical excitability measures	We will measure cortical excitability using single pulse transcranial magnetic stimulation (TMS) before and after 1st stimulation session. We will compare the measurements from before stimulation to after stimulation.	Baseline
Secondary	Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer		Baseline and immediately following the 4 weeks intervention