CClinicalTrials.gg
Status unknownNCT02393391Updated Mar 19, 2015

A Novel Non Invasive Brain Stimulation Based Treatment for Chronic Low Back Pain (CLBP)

A Phase 2/3 interventional study of Neuroelectrics STARSTIM in Chronic Low Back Pain, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-19.

Sponsored by Tel-Aviv Sourasky Medical Center · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Low Back Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age 18 to 70
  2. CLBP as defined by the European guidelines

Exclusion criteria

Exclusion Criteria:

  1. Acute low back pain (duration of less than 6 months
  2. Neurological illness causing structural brain damage (e.g. Stroke, TIA)
  3. Psychiatric disease other than mood disorders
  4. Current chronic use of medications with pro-epileptic properties
  5. Known alcohol dependency
  6. Use of alcohol within the previous 24 hours
  7. History of loss of consciousness
  8. Epilepsy or epilepsy in a first degree relative
  9. Medical implants
  10. Pregnancy
  11. Illicit drug use or within the previous month
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • 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

    Device: Neuroelectrics STARSTIM

  • 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

    Device: Neuroelectrics STARSTIM

Interventions

  • DeviceNeuroelectrics STARSTIM
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02393391
Lead sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
NIBS NeuroScience Technologies
Responsible party
Sponsor
First posted
Mar 19, 2015
Start date
May 2015
Primary completion
May 2015 (estimated)
Last update
Mar 19, 2015

Study contacts

Silviu Brill, Dr.
Contact
paincenter@tlvmc.gov.il
97236974581

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion