Chronic Low Back PainPhase 2/3NCT02393391
A Novel Non Invasive Brain Stimulation Based Treatment for Chronic Low Back Pain (CLBP)
A Phase 2/3 study testing Neuroelectrics STARSTIM in people with Chronic Low Back Pain, run by Tel-Aviv Sourasky Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Neuroelectrics STARSTIM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 to 70
- CLBP as defined by the European guidelines
Who cannot join
- 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
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- History of loss of consciousness
- Epilepsy or epilepsy in a first degree relative
- Medical implants
- Pregnancy
- Illicit drug use or within the previous month
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Neuroelectrics STARSTIM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroelectrics STARSTIMDevice
| Study group | Role | What they receive |
|---|---|---|
| NIBS tDCS/tACS stimulation | Active comparator | 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 Receives: Device: Neuroelectrics STARSTIM |
| inactive electrodes | Placebo comparator | 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 Receives: Device: Neuroelectrics STARSTIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of treatment efficacy (evaluated by pain level and sleep quality questionnaire)
Efficacy of the treatment will be evaluated by pain level and sleep quality questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- NIBS NeuroScience Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393391
- Sponsor's protocol ID
- TASMC-14-SB-600-CTIL
- Status last verified
- Mar 2015
- First submitted
- 8 Mar 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Non Invasive Brain Stimulation Based Treatment for Chronic Low Back
- ClinicalTrials.gov ID
- NCT02393391
- Acronym / sponsor ID
- TASMC-14-SB-600-CTIL
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- NIBS NeuroScience Technologies
- Study start
- May 2015
- Primary completion
- May 2015 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIBS tDCS/tACS stimulation | Active comparator | Device: Neuroelectrics STARSTIMEach 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 |
| inactive electrodes | Placebo comparator | Device: Neuroelectrics STARSTIMdiagnosis 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 to 70
- CLBP as defined by the European guidelines
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroelectrics STARSTIM | Device | NIBS tDCS/tACS stimulation, inactive electrodes |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Neuroelectrics STARSTIM in people with Chronic Low Back Pain, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silviu Brill, Dr. (97236974581, paincenter@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of treatment efficacy (evaluated by pain level and sleep quality questionnaire) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.