Clinical trial NCT03625752: Optimization of NIBS for Diabetic Neuropathy Neuropathic Pain
Official title: Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Neuropathies
Chronic Pain
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: Highland Instruments, Inc.
First posted: 2018-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, double-blinded, placebo controlled, randomized study.
Primary purpose: TREATMENT

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.

Detailed description: Active stimulation will be compared with compared to SHAM stimulation 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, 40 DNP patients will be enrolled, 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).

Eligibility 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).

Primary outcomes:
measure: Changes in pain as measured by the Visual Analog Scale (VAS)
timeFrame: Measured for approximately 3 months
Secondary outcomes:
measure: Changes in the Verbal Rating Scale (VRS) for Pain
timeFrame: Measured for approximately 3 months
measure: Changes in Conditional Pain Modulation
timeFrame: Measured for approximately 3 months
measure: Changes in Visual Analog Scalefor Mood (VAMS)
timeFrame: Measured for approximately 3 months
measure: Montreal Cognitive Assessment
timeFrame: Measured for approximately 3 months
measure: 4-choice reaction time
timeFrame: Measured for approximately 3 months
measure: N-back tests
timeFrame: Measured for approximately 3 months
measure: Electroencephalography
timeFrame: Measured for approximately 3 months
measure: Walking test
timeFrame: Measured for approximately 3 months
measure: Functional reach test
timeFrame: Measured for approximately 3 months
measure: Study 36-Item Short Form (SF-36)
timeFrame: Measured for approximately 3 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Measured for approximately 3 months
measure: American Pain Foundation Pain and Medication Diary
timeFrame: Measured for approximately 3 months
measure: Multidimensional Pain Inventory (MPI)
timeFrame: Measured for approximately 3 months
measure: Brief Pain Inventory-DPN
timeFrame: Measured for approximately 3 months
measure: Adverse events
timeFrame: Measured for approximately 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ciro Ramos Estebanez
state: Illinois
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center/ Dahms Clinical Research Unit
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center/ Case Western Reserve University
name: Salim Hayek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: