Transcranial Direct Current Stimulation Aided Rehabilitation of Gait in Subacute Stroke

NCT01927458 | Terminated

• 1 other identifier: M-2012-570-12
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Maximal gait speed using the 10-m walking test

  Baseline and follow up immediately following the 4 weeks intervention

Secondary Outcomes (2)

• Changes in cortical excitability measures

  Baseline

• Dynamometry: the maximal isometric force of muscles will be assessed by Biodex System 3 PRO dynamometer

  Baseline and immediately following the 4 weeks intervention

Study Arms (1)

anodal tDCS with treadmill training

EXPERIMENTAL

Each subject will receive 4 weeks gait treadmill training at least 3 days per week in combination with anodal transcranial Direct Current Stimulation over the primary motor cortex up to 20 min

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue

Also known as: Non.invasive brain stimulation

anodal tDCS with treadmill training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications to MRI or TMS
• Other neurological disorders
• Significant somatic or psychiatric disorders
• History of seizures
• Language or cognitive disorders prohibiting participation

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Hammel Neurocenter

Hammel, 8450, Denmark

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Henning Andersen, Professor

  University of Aarhus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 22, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

DK (1)