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Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT03625752
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : January 11, 2022
Sponsor:
Collaborator:
Highland Instruments, Inc.
Information provided by (Responsible Party):
Ciro Ramos Estebanez, Case Western Reserve University

Study Description
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Brief Summary:
The purpose of this study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain. The investigators hypothesize that there will be a decrease in pain levels with active stimulation when compared to sham stimulation.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Chronic Pain Device: Active Comparator: Active tDCS + Active TUS Device: Sham Not Applicable

Detailed Description:

We hypothesize that Active stimulation will have a significantly improved and lasting effect compared to SHAM stimulation assessed in DNP patients.

20 DNP patients, 10 per group, receive stimulation or sham for 5 consecutive days, 20 min/day, followed by 2, 4, and 6 weeks post-therapy. 9 visits plus screening/baseline (total 10 visits).

Subsequently, we will enroll 40 DNP patients, 20 per group, giving 5 consecutive days, 20 min/day, followed by 2 weeks of bi-weekly stimulation or sham for 20 min/day (total stimulations n=9) and follow-ups at 2, 4, 6, & 8 weeks post-stim): 13 visits plus screening/ baseline (total 14 visits).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-center, double-blinded, placebo controlled, randomized study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : June 7, 2023
Estimated Study Completion Date : June 7, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active Comparator: Active tDCS + Active TUS
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
 Device: Active Comparator: Active tDCS + Active TUS
Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Sham Comparator: Sham
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
 Device: Sham
Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in pain as measured by the Visual Analog Scale (VAS) [ Time Frame: Measured for approximately 3 months ]
    The scale will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable). Changes in VAS for Pain will be measured to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.


Secondary Outcome Measures :
  1. Changes in the Verbal Rating Scale (VRS) for Pain [ Time Frame: Measured for approximately 3 months ]
    The VRS for Pain is a categorical scale of pain with categories: none, mild, moderate, severe pain intensity. Changes in VRS for Pain will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction. with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.

  2. Changes in Conditional Pain Modulation [ Time Frame: Measured for approximately 3 months ]
    Changes in Conditional Pain Modulation (CPM) will be measured in order to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in increasing the pain pressure threshold in subjects with diabetic neuropathic pain.

  3. Changes in Visual Analog Scalefor Mood (VAMS) [ Time Frame: Measured for approximately 3 months ]

    The VAS for Mood will investigate Anxiety, Depression, Stress, and Sleepiness. The Subscales are as follows:

    The anxiety scale will assess a patient's anxiety on a scale from 0 (not anxious) to 10 (very anxious).

    The depression scale will assess a patient's depression on a scale from 0 (not depressed) to 10 (very depressed).

    The stress scale will assess a patient's stress on a scale from 0 (not stressed) to 10 (very stressed).

    The sleepiness scale will assess a patient's depression on a scale from 0 (not sleepy) to 10 (very sleepy).


  4. Montreal Cognitive Assessment [ Time Frame: Measured for approximately 3 months ]
    The investigators will monitor the safety of tDCS and TUS in subjects by measuring any changes in cognition. Scores range from lowest being 0 to highest being 30.

  5. 4-choice reaction time [ Time Frame: Measured for approximately 3 months ]
    This is an attentional task that measures the time for a subject response to stimuli (in seconds) with shorter times being better.

  6. N-back tests [ Time Frame: Measured for approximately 3 months ]
    Assesses registration and immediate recall on a scale of the number of items correctly responded to

  7. Electroencephalography [ Time Frame: Measured for approximately 3 months ]
    Investigators will measure electroencephalogram (EEG) electrical activity (EEG amplitude and EEG frequency) as function of time.

  8. Walking test [ Time Frame: Measured for approximately 3 months ]
    The investigators will measure if there are changes in the walking speed, gait asymmetry, stride length, and walking smoothness of the subject from the beginning of the study to the end

  9. Functional reach test [ Time Frame: Measured for approximately 3 months ]
    The investigators will measure changes in subjects ability to complete the functional reach test across the duration of study.

  10. Study 36-Item Short Form (SF-36) [ Time Frame: Measured for approximately 3 months ]
    This is a health survey using a scale from 0 (worst) to 100 (best)

  11. Patient Health Questionnaire (PHQ-9) [ Time Frame: Measured for approximately 3 months ]
    This questionnaire screens for depression with a score of 0 (best) to 27 (worst)

  12. American Pain Foundation Pain and Medication Diary [ Time Frame: Measured for approximately 3 months ]
    The pain sub-scale measures pain intensity from 0 (best) to 10 (worst)

  13. Multidimensional Pain Inventory (MPI) [ Time Frame: Measured for approximately 3 months ]
    This pain scale measures aspects of pain from 0 (best) to 6 (worst)

  14. Brief Pain Inventory-DPN [ Time Frame: Measured for approximately 3 months ]
    This pain scale measures aspects of pain from 0 (no pain) to 10 (worst)

  15. Adverse events [ Time Frame: Measured for approximately 3 months ]
    At each session after stimulation begins, subjects will complete a questionnaire to evaluate potential adverse effects of stimulation (headache, neck pain, mood alterations, and seizures) on a 5-point scale (0 being best and 5 worst). The scale will also be administered at the follow-up.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to provide informed consent to participate in the study.
  2. Subjects between 40 to 80 years old.
  3. Having diabetic neuropathic pain, involving at least 1 foot, with existing pain for at least 6 months, and having pain on at least half the days in the past 6 months with an average of at least a 4 on a 0-10 VAS scale).
  4. Having pain resistant to common analgesics and medications for first-line therapy of chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, Codeine, etc.
  5. Must have the ability to feel pain as self-reported.

Exclusion Criteria:

  1. Subject is pregnant.
  2. Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
  3. History of alcohol or drug abuse within the past 6 months as self-reported.
  4. Use of carbamazepine within the past 6 months as self-reported.
  5. Suffering from severe depression (with a PHQ 9 score of ≥ 10).
  6. History of neurological disorders as self-reported.
  7. History of unexplained fainting spells as self-reported.
  8. History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.
  9. History of neurosurgery as self-reported.
  10. Unstable pain (defined as pain intensities that vary by more than 4 points on 0-10 VAS scale over the 1-week period of trial run-in).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625752


Contacts
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Contact: Megan O'Neill Miller 216-844-4720 megan.miller3@uhhospitals.org
Contact: Kimberly Puskus (216) 844-3194 kimberly.puskus@uhhospitals.org

Locations
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United States, Illinois
Ciro Ramos Estebanez Recruiting
Chicago, Illinois, United States, 60612
Contact: Ciro Ramos Estebanez, MD., Ph.D.       cramoses@uic.edu   
Principal Investigator: Ciro Ramos Estebanez, MD., Ph.D.         
United States, Ohio
University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit Recruiting
Cleveland, Ohio, United States, 44106-1716
Contact: Jillian Russell, MSN, RN-BC    216-844-4901    Jillian.Russell@uhhospitals.org   
Contact: Ciro Ramos Estebanez, MD, PhD       cre22@case.edu   
Sponsors and Collaborators
Case Western Reserve University
Highland Instruments, Inc.
Investigators
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Principal Investigator: Salim Hayek, MD PhD University Hospitals Cleveland Medical Center/ Case Western Reserve University
More Information
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Responsible Party: Ciro Ramos Estebanez, Neurology faculty, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03625752    
Other Study ID Numbers: STUDY20180314-2/20201584
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Chronic Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases