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出境医 / 临床实验 / Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation (HomeStim)

Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation (HomeStim)

Study Description
Brief Summary:

The aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past.

Furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.


Condition or disease Intervention/treatment Phase
Glaucoma Electrical Stimulation Home Treatment Procedure: Transorbital electrical stimulation Phase 1 Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Arm Intervention/treatment
rtACS
repetitive transorbital ACS
Procedure: Transorbital electrical stimulation
Transorbital ACS using 8-12 Hz with 0,5-1,5 mA Intensity, during the first two weeks 1/day, after 2/week for 10 weeks, as a home treatment

Outcome Measures
Primary Outcome Measures :
  1. Visual field size [ Time Frame: 3 months ]
    Static perimetry and high resolution perimetry will be used to measure the visual field sizes


Secondary Outcome Measures :
  1. EEG connectivities in the visual system [ Time Frame: 3 months ]
    EEG recordings will be done using 128 channels, power spectra will be determined

  2. Level of vascular regulation/dysregulation in the eye [ Time Frame: 3 months ]
    Dynamic vessel analysis will be used the measure blood flow in the eye


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with glaucoma, disease duration at least 6 months
  • stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
  • presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
  • best corrected visual acuity at least 0.4 (20/50 Snellen) or better

Exclusion Criteria:

  • autoimmune diseases in the acute stage
  • neurological and mental diseases
  • diabetic retinopathy
  • addictions
  • hypertension (maximum 160/100 mmHg)
  • retinitis pigmentosa-
  • pathological nystagmus
  • non-distant tumors or recurrent tumors
  • photosensitivity
  • pregnancy
  • electric or electronic implants (e.g. heart pacemaker)
  • metal implants in the eyes or head (with the exception of dental prosthesis or shunts)
Contacts and Locations

Locations
Layout table for location information
Germany
Institute of Medical Psychology
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE August 5, 2019
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
Visual field size [ Time Frame: 3 months ]
Static perimetry and high resolution perimetry will be used to measure the visual field sizes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • EEG connectivities in the visual system [ Time Frame: 3 months ]
    EEG recordings will be done using 128 channels, power spectra will be determined
  • Level of vascular regulation/dysregulation in the eye [ Time Frame: 3 months ]
    Dynamic vessel analysis will be used the measure blood flow in the eye
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation
Official Title  ICMJE Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
Brief Summary

The aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past.

Furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Electrical Stimulation
  • Home Treatment
Intervention  ICMJE Procedure: Transorbital electrical stimulation
Transorbital ACS using 8-12 Hz with 0,5-1,5 mA Intensity, during the first two weeks 1/day, after 2/week for 10 weeks, as a home treatment
Study Arms  ICMJE rtACS
repetitive transorbital ACS
Intervention: Procedure: Transorbital electrical stimulation
Publications * Gall C, Schmidt S, Schittkowski MP, Antal A, Ambrus GG, Paulus W, Dannhauer M, Michalik R, Mante A, Bola M, Lux A, Kropf S, Brandt SA, Sabel BA. Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. PLoS One. 2016 Jun 29;11(6):e0156134. doi: 10.1371/journal.pone.0156134. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Actual Enrollment  ICMJE
 (submitted: July 4, 2019)
50
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with glaucoma, disease duration at least 6 months
  • stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
  • presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
  • best corrected visual acuity at least 0.4 (20/50 Snellen) or better

Exclusion Criteria:

  • autoimmune diseases in the acute stage
  • neurological and mental diseases
  • diabetic retinopathy
  • addictions
  • hypertension (maximum 160/100 mmHg)
  • retinitis pigmentosa-
  • pathological nystagmus
  • non-distant tumors or recurrent tumors
  • photosensitivity
  • pregnancy
  • electric or electronic implants (e.g. heart pacemaker)
  • metal implants in the eyes or head (with the exception of dental prosthesis or shunts)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04010994
Other Study ID Numbers  ICMJE StimulationMagd
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be available without restriction
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After publication
Access Criteria: Contact to the Principal investigator
Responsible Party Bernhard A. Sabel, University of Magdeburg
Study Sponsor  ICMJE University of Magdeburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Magdeburg
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP