- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02393391
A Novel Non Invasive Brain Stimulation Based Treatment for Chronic Low Back Pain (CLBP)
March 18, 2015 updated by: Tel-Aviv Sourasky Medical Center
Novel Non Invasive Brain Stimulation Based Treatment for Chronic Low Back
Neuropathic pain results from damage to or dysfunction of the peripheral or central nervous system, rather than stimulation of pain receptors.
Diagnosis is suggested by pain out of proportion to tissue injury, dysesthesia (eg, burning, tingling), and signs of nerve injury detected during neurologic examination.
Although neuropathic pain responds to opioids, treatment is often with adjuvant drugs (eg, antidepressants, anticonvulsants, baclofen, topical drugs).
Neuropathic pain (e.g.
phantom limb pain, CRPS, postherpetic neuralgia, postsurgical pain syndromes, CLBP etc.) remains a challenging condition to treat because it is commonly refractory to classical pharmacological and to surgical treatment approaches.
Chronic low back pain (CLBP) is a widespread and costly problem for which few interventions are effective.
An increased focus on the study of the nervous system and its involvement in pain disorders has documented complex neuronal activity and structural changes at a peripheral, as well as at spinal cord and cortical levels indicating a neuropathic element in CLBP.
Accumulated evidence suggests that neuropathic pain in general and CLBP specifically might be associated to brain cortical plastic changes.
Thus an ideal rehabilitative approach should aim to reverse them.
In line with this idea, the investigators suggest an innovative noninvasive intervention aimed at alleviating neuropathic pain.
New rehabilitative approaches have been proposed to try and reverse this cortical reorganization.
Results of several studies have shown that motor cortex stimulation with epidural electrodes or repetitive transcranial magnetic stimulation (rTMS) or transcranial direct stimulation (tDCS) are effective in reducing pain in patients with central pain refractory to treatment.
Transcranial direct current stimulation (tDCS) is an easily applied and safe technique by which brain activity can be modulated noninvasively and can decrease pain in patients with refractory central pain.
The investigators hypothesized that focal-tDCS treatment personally customized to each patients basal neuronal network properties would result in both acute and long term pain relief for neuropathic pain patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Silviu Brill, Dr.
- Phone Number: 97236974581
- Email: paincenter@tlvmc.gov.il
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 18 to 70
- CLBP as defined by the European guidelines
Exclusion Criteria:
- Acute low back pain (duration of less than 6 months
- Neurological illness causing structural brain damage (e.g. Stroke, TIA)
- Psychiatric disease other than mood disorders
- Current chronic use of medications with pro-epileptic properties
- Known alcohol dependency
- Use of alcohol within the previous 24 hours
- History of loss of consciousness
- Epilepsy or epilepsy in a first degree relative
- Medical implants
- Pregnancy
- Illicit drug use or within the previous month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: NIBS tDCS/tACS stimulation
Each patient will undergo initial diagnosis with NIBS algorithm utilizing EEG measurements combined with TMS.
Initial diagnosis will last 10 minutes in which EEG measurement will be recorded 5 minutes and then in combination with TMS for another 5 minutes with no more than 500 TMS stimuli applied to cortex at low frequency of up to 5Hz.
EEG recording will be analyzed by NIBS algorithm which will propose a course of treatment with the following limitations: stimulation of 2mA (32, 33) current after 30 seconds ramp up of 0.1mA increments, 20 min for each session, twice a week
|
|
Placebo Comparator: inactive electrodes
diagnosis and monitoring will be performed as in active treatment, but during treatment anodal/cathodal/alternate stimulation will begin and automatically stop after 30 seconds leaving subject with an inactive electrodes in place for the remainder of treatment duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of treatment efficacy (evaluated by pain level and sleep quality questionnaire)
Time Frame: one year
|
Efficacy of the treatment will be evaluated by pain level and sleep quality questionnaire
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
March 8, 2015
First Submitted That Met QC Criteria
March 18, 2015
First Posted (Estimate)
March 19, 2015
Study Record Updates
Last Update Posted (Estimate)
March 19, 2015
Last Update Submitted That Met QC Criteria
March 18, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-14-SB-600-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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