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

NCT00909714 | Completed DMC

• 1 other identifier: NETS Trial
• Study Type: interventional
• Target: 119
• Locations: 3 countries
• Sites: 11

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; non-invasive cortical stimulation; motor recovery; cortical plasticity; TDCS

Outcome Measures

Primary Outcomes (1)

• Upper Extremity Fugl-Meyer-Assessment (UEFMA)

  standardized test of upper extremity function

  1-7 days after the end of the intervention

Secondary Outcomes (23)

• Upper Extremity Fugl-Meyer-Assessment (UEFMA)

  30±10 days after the intervention

• Upper Extremity Fugl-Meyer-Assessment (UEFMA)

  90±20 days after the intervention

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

  12±1 months after the intervention

• Action Research Arm Test (ARAT)

  1-7 days after the end of the intervention

• Action Research Arm Test (ARAT)

  30±10 days after the intervention

Study Arms (2)

Anodal tDCS

EXPERIMENTAL

Direct Current (DC)-Stimulator to apply tDCS + Training

Device: DC-Stimulator to apply tDCS

Sham tDCS

SHAM COMPARATOR

Direct Current (DC)-Stimulator to apply Sham tDCS (Placebo) + Training

Device: DC-Stimulator to apply Sham tDCS

Interventions

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

Anodal tDCS

DC-Stimulator to apply Sham tDCS DEVICE

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

Sham tDCS

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (11)

Neurologische Universitätsklinik Wien

Vienna, Vienna, 1090, Austria

Location

Klinik Kipfenberg

Kipfenberg, Bavaria, 85110, Germany

Location

Brandenburgklinik Berlin-Brandenburg

Bernau Bei Berlin, State of Berlin, 16321, Germany

Location

Neurologie Moritzklinik

Bad Klosterlausnitz, Thuringia, 07639, Germany

Location

Neurologische Klinik Bad Aibling

Bad Aibling, 83043, Germany

Location

Neurologisches Zentrum Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

NRZ Leipzig

Bennewitz, 04828, Germany

Location

MEDIAN Klinik Berlin-Kladow

Berlin, 14089, Germany

Location

University Medical Center Hamburg Eppendorf (UKE)

Hamburg, 20246, Germany

Location

University Medical Center Heidelberg

Heidelberg, 69120, Germany

Location

Fondazione Santa Lucia

Rome, 00179, Italy

Location

Related Publications (3)

• NETS Trial Collaboration Group. A multicenter, randomized, double-blind, placebo-controlled trial to test efficacy and safety of transcranial direct current stimulation to the motor cortex after stroke (NETS): study protocol. Neurol Res Pract. 2022 Apr 18;4(1):14. doi: 10.1186/s42466-022-00171-2.

  PMID: 35430801 BACKGROUND

• NETS Trial Collaboration Group. Efficacy and safety of transcranial direct current stimulation to the ipsilesional motor cortex in subacute stroke (NETS): a multicenter, randomized, double-blind, placebo-controlled trial. Lancet Reg Health Eur. 2024 Jan 2;38:100825. doi: 10.1016/j.lanepe.2023.100825. eCollection 2024 Mar.

  PMID: 38476746 BACKGROUND

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

  PMID: 33175411 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian Gerloff, Prof. Dr.

  Department of Neurology, University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 28, 2009
• Study Start: July 1, 2009
• Primary Completion: February 19, 2021
• Study Completion: March 31, 2021
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 24 months after main publication.
• Access Criteria: Personal login into UKE data repository.

Locations

DE (9); AU (1); IT (1)