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Completed

NCT Number: NCT00909714

Neuroregeneration Enhanced by Transcranial Direct Current Stimulation (TDCS) in Stroke

Testing the hypothesis that non-invasive brain stimulation by transcranial direct current stimulation (tDCS) combined with functional training in the subacute phase of first-ever stroke will enhance functional regeneration compared with a Placebo intervention.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurologische Universitätsklinik Wien, Vienna, State of Vienna, Austria

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About this study

Stroke is the leading cause of long-term disability, which significantly impairs the economic and social life of patients and society. Every year 200 000 to 250 000 patients suffer a stroke in Germany. Only a small number of the stroke survivors recover to a degree that allows them to return into their professional and private life. Despite significant efforts to develop novel and efficient treatment strategies the level of functional regeneration is still not satisfying. Thus, the development of innovative and effective treatment strategies will have a major impact for the patients' life, the society and the public health system.

Within the proposed project an innovative, non-invasive and cost effective interventional strategy, based on the combination of a specific rehabilitative training and brain stimulation by transcranial direct current stimulation (tDCS), will be used to enhance functional regeneration in stroke patients. The intervention will be applied in an early stage in which plasticity, cortical reorganization and functional improvement is most pronounced. We hypothesize that the combination of anodal tDCS delivered to the motor cortex of the affected hemisphere combined with training over a period of two weeks in the subacute stage after stroke will significantly enhance cortical plasticity, functional regeneration and long-term outcome determined by clinical and functional outcome measures compared with Placebo stimulation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subacute stroke patients (5-45 days after stroke) with thromboembolic non-hemorrhagic subcortical or cortical, first clinically overt stroke will be included. Moderate to moderately severe upper-extremity hemiparesis, defined as an Upper Extremity Fugl-Meyer score (UEFMA) between 20 and 58 (inclusive).

Exclusion criteria

  • pre-existing large lesions (> 1.5 cm maximum diameter) in a brain area that belongs to the anatomically established sensorimotor/premotor system
  • progressive stroke
  • completely lesioned hand knob area of M1 affected if no motor evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) are present
  • bilateral motor impairment
  • florid alcohol and/or drug abuse
  • florid severe psychiatric illness (e.g. schizophrenia)
  • severe language disturbances that prevents the patient to give informed consent or inhibit adequate scoring because of insufficient understanding of scoring introductions
  • tumor diseases with a life expectancy less than one year
  • increased intracranial pressure
  • polyneuropathy and/or ischemic peripheral disease if the sensorimotor functions of the upper extremities are affected clinically relevant
  • severe cognitive deficits (MMSE ≤ 23)
  • pregnancy
  • contraindication for MRI or TMS

Treatment and study plan

DC-Stimulator to apply tDCS

Device

Anodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

DC-Stimulator to apply Sham tDCS

Device

Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

Primary outcomes

  1. Upper Extremity Fugl-Meyer-Assessment (UEFMA)

    Time frame: 1-7 days after the end of the intervention

    standardized test of upper extremity function

Secondary outcomes

  1. Upper Extremity Fugl-Meyer-Assessment (UEFMA)

    Time frame: 30±10 days after the intervention

    standardized test of upper extremity function

  2. Upper Extremity Fugl-Meyer-Assessment (UEFMA)

    Time frame: 90±20 days after the intervention

    standardized test of upper extremity function

  3. Upper Extremity Fugl-Meyer-Assessment (UEFMA) | Long-term outcome

    Time frame: 12±1 months after the intervention

    standardized test of upper extremity function

  4. Action Research Arm Test (ARAT)

    Time frame: 1-7 days after the end of the intervention

    standardized tests of upper extremity function

  5. Action Research Arm Test (ARAT)

    Time frame: 30±10 days after the intervention

    standardized tests of upper extremity function

  6. Action Research Arm Test (ARAT)

    Time frame: 90±20 days after the intervention

    standardized tests of upper extremity function

  7. Action Research Arm Test (ARAT) | Long-term outcome

    Time frame: 12±1 months after the intervention

    standardized tests of upper extremity function

  8. Nine Hole Peg Test (NHPT)

    Time frame: 1-7 days after the end of the intervention

    standardized test to assess fine motor skills

  9. Nine Hole Peg Test (NHPT)

    Time frame: 30±10 days after the intervention

    standardized test to assess fine motor skills

  10. Nine Hole Peg Test (NHPT)

    Time frame: 90±20 days after the intervention

    standardized test to assess fine motor skills

  11. Nine Hole Peg Test (NHPT) | Long-term outcome

    Time frame: 12±1 months after the intervention

    standardized test to assess fine motor skills

  12. Stroke Impact Scale (SIS)

    Time frame: 1-7 days after the end of the intervention

    questionnaire is to evaluate how stroke has impacted health and life of patients

  13. Stroke Impact Scale (SIS)

    Time frame: 30±10 days after the intervention

    questionnaire is to evaluate how stroke has impacted health and life of patients

  14. Stroke Impact Scale (SIS)

    Time frame: 90±20 days after the intervention

    questionnaire is to evaluate how stroke has impacted health and life of patients

  15. Stroke Impact Scale (SIS) | Long-term outcome

    Time frame: 12±1 months after the intervention

    questionnaire is to evaluate how stroke has impacted health and life of patients

  16. Box-and-Block Test

    Time frame: 1-7 days after the end of the intervention

    standardized test to assess fine motor skills

  17. Box-and-Block Test

    Time frame: 30±10 days after the intervention

    standardized test to assess fine motor skills

  18. Box-and-Block Test

    Time frame: 90±20 days after the intervention

    standardized test to assess fine motor skills

  19. Box-and-Block Test

    Time frame: 12±1 months after the intervention

    standardized test to assess fine motor skills

  20. Grip Force

    Time frame: 1-7 days after the end of the intervention

    dynamometer-based test to assess grip strength

  21. Grip Force

    Time frame: 30±10 days after the intervention

    dynamometer-based test to assess grip strength

  22. Grip Force

    Time frame: 90±20 days after the intervention

    dynamometer-based test to assess grip strength

  23. Grip Force

    Time frame: 12±1 months after the intervention

    dynamometer-based test to assess grip strength

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Neuroregeneration Enhanced by TDCS in Stroke

Acronym: NETS

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
May 28, 2009
Registry last updated
Dec 11, 2024

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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