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Completed

NCT Number: NCT01969097

Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke

The aim of the study is to investigate whether the combination of bihemispheric ("dual") transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Results will be compared to a matched group of patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic stroke (>6 months after stroke)
  • age: 18 to 80 years
  • non-hemorrhagic or hemorrhagic stroke

Exclusion criteria

  • more than 1 stroke
  • severe alcohol disease or drug abuse, severe psychiatric disease like depression or psychosis
  • severe cognitive deficits
  • severe untreated medical conditions
  • other neurologic diseases
  • severe microangiopathy
  • pregnancy

Treatment and study plan

tDCS

Device

transcranial direct current stimulation (tDCS)

motor training

Behavioral

Motor training of the affected upper extremity (5 days, 25 min/day).

Primary outcomes

  1. Motor Function of the Affected Upper Extremity

    Time frame: Change from baseline after 5 days (immediately after intervention)

    Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).

  2. Motor Function of the Affected Upper Extremity

    Time frame: change from baseline after 3 months

    Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).

Secondary outcomes

  1. Motor Function of the Affected Upper Extremity

    Time frame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)

    Effects of dual tDCS + training vs anodal tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).

  2. Functional Magnetic Resonance Imaging

    Time frame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)

    Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on task-specific activations and functional connectivity (measured by functional Magnetic Resonance Imaging, fMRI).

  3. Diffusion Tensor Imaging

    Time frame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)

    Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on cerebral microstructure (measured by Diffusion Tensor Imaging, DTI).

  4. Transcranial Magnetic Stimulation

    Time frame: After 5 days vs baseline (before intervention)

    Effects of dual tDCS + training vs anodal tDCS + training vs sham tDCS + training on excitability of the primary motor cortex (measured by Motor Evoked Potentials, MEP, using Transcranial Magnetic Stimulation, TMS).

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
First posted
Oct 25, 2013
Registry last updated
Mar 17, 2016

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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