Neuropathic PainNCT01560039
Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain
A study testing TMS and Neurofeedback in people with Neuropathic Pain, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Chronic neuropathic pain is a global health concern, affecting millions of patients worldwide. It is often extremely debilitating and poses a diagnostic and therapeutic challenge. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- TMS and Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Apr 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old, treated medically for neuropathic pain of an upper arm with unsatisfactory results (average daily VAS score over 4)
Who cannot join
- Cognitive decline,
- malignant disease,
- focal neurological deficit,
- illegal substance abuse
- noncompliance with medical therapy or follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voluntary Modulation of M1 Motor Cortex Activity Using EEG Neurofeedback for the Treatment of Resistant Chronic Neuropathic Pain - a Clinical and fMRI Study
Chronic neuropathic pain is a global health concern, affecting millions of patients worldwide. It is often extremely debilitating and poses a diagnostic and therapeutic challenge. The current mainstay of treatment is pharmacotherapy consisting of powerful analgesics combined with different classes of drugs that change nerve cell membrane properties. However, response to pharmacotherapy is often poor and mandates interventional strategies. Among the latest and most promising interventional strategies is the use of neurostimulation to targeted brain areas, specifically the primary motor cortex . Motor cortex stimulation , both invasive and noninvasive (using megnetic or electical stimulation), has emerged as a highly beneficial treatment, and is currently included in different professional guidelines for the treatment of medically refractory neuropathic pain.
A possible alternative way to achieve stimulation of the motor cortex is by using EEG based neurofeedback. This design, which is actually a Brain Computer Interface (BCI) enables the patient to voluntarily modulate the activity of a circumscribed brain area after a few training sessions. While EEG based neurofeedfback is decades old, it has never been tested in neuropathic pain patients.
This experiment is intended to compare both the clinical effects and the brain correlates of a BCI based self modulation of M1 activity and of exogenous magnetic brain stimulation in a population of patients suffering from chronic neuropathic pain of an upper limb. 15 such patients will receive a course of 10 daily magnetic stimulation sessions with stimulation of M1 as described in the literature. A further 30 patients will be divided into two groups: 15 will perform a course of 10 real BCI neurofeedback sessions modulating motor cortex activity and 15 will perform a course of 10 sham neurofeedback sessions. The participants' baseline chronic pain levels and their response to acute painful stimuli will be clinically evaluated before and after the course, and for an additional 1 month. Furthermore, before and after the course patients will be scanned using functional MRI during rest (baseline pain levels) and during acute pain. These scans are performed both to describe the neural correlates of the analgesia induced by motor cortex magnetic stimulation , and to compare the observed networks to the network effect of a BCI neurofeedback modulation of motor cortex activity.
- Conditions
- Neuropathic Pain
- Being tested
- TMS, Neurofeedback, Sham neurofeedback
- Keywords
- Neuropathic pain, neurostimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Transcranial magentic stimulation of the motor cortex. Device Details : Model is Magstim TMS Rapid. Manufacturer : MAGSTIM CO LTD. Spring Gardens, Whitland, Carmarthenshire, Wales, U.K., SA34 0HR
NeurofeedbackOther
EEG neurofeedback based on the primary motor cortex
Sham neurofeedbackOther
Sham EEG neurofeedback
| Study group | Role | What they receive |
|---|---|---|
| Real EEG-NF | Active comparator | 10 EEG based neurofeedback sessions modulating the activity of the primary motor cortex Receives: Other: Neurofeedback |
| Sham EEG-NF | Sham comparator | 10 sessions of Sham EEG_NF of the motor cortex area Receives: Other: Sham neurofeedback |
| Transcrainal Magnetic Stimulation | Active comparator | 10 dailt TMS stimulation sessions of M1 Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily pain levels
daily pain levels will be assessed using a visual assessment score (VAS) during the treament phase (lasting aproximately 3 weeks)
Measured: during three weeks of treatments
Secondary outcomes (1)
Daily pain measures for one month following the last session
Daily pain scores based on the VAS (visual-analogue scale) system will be assessed for a further one month following the last treatment session.
Measured: one month following the last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Talma Hendler, MD, PhD, Study director, Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560039
- Sponsor's protocol ID
- TASMS-12-HS-0577-11-TLV-CTIL
- Status last verified
- Mar 2012
- First submitted
- 12 Mar 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voluntary Modulation of M1 Motor Cortex Activity Using EEG Neurofeedback for the Treatment of Resistant Chronic Neuropathic Pain - a Clinical and fMRI Study
- ClinicalTrials.gov ID
- NCT01560039
- Acronym / sponsor ID
- TASMS-12-HS-0577-11-TLV-CTIL
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic pain, neurostimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 21 Mar 2012 (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.
Chronic neuropathic pain is a global health concern, affecting millions of patients worldwide. It is often extremely debilitating and poses a diagnostic and therapeutic challenge. The current mainstay of treatment is pharmacotherapy consisting of powerful analgesics combined with different classes of drugs that change nerve cell membrane properties. However, response to pharmacotherapy is often poor and mandates interventional strategies. Among the latest and most promising interventional strategies is the use of neurostimulation to targeted brain areas, specifically the primary motor cortex . Motor cortex stimulation , both invasive and noninvasive (using megnetic or electical stimulation), has emerged as a highly beneficial treatment, and is currently included in different professional guidelines for the treatment of medically refractory neuropathic pain.
A possible alternative way to achieve stimulation of the motor cortex is by using EEG based neurofeedback. This design, which is actually a Brain Computer Interface (BCI) enables the patient to voluntarily modulate the activity of a circumscribed brain area after a few training sessions. While EEG based neurofeedfback is decades old, it has never been tested in neuropathic pain patients.
This experiment is intended to compare both the clinical effects and the brain correlates of a BCI based self modulation of M1 activity and of exogenous magnetic brain stimulation in a population of patients suffering from chronic neuropathic pain of an upper limb. 15 such patients will receive a course of 10 daily magnetic stimulation sessions with stimulation of M1 as described in the literature. A further 30 patients will be divided into two groups: 15 will perform a course of 10 real BCI neurofeedback sessions modulating motor cortex activity and 15 will perform a course of 10 sham neurofeedback sessions. The participants' baseline chronic pain levels and their response to acute painful stimuli will be clinically evaluated before and after the course, and for an additional 1 month. Furthermore, before and after the course patients will be scanned using functional MRI during rest (baseline pain levels) and during acute pain. These scans are performed both to describe the neural correlates of the analgesia induced by motor cortex magnetic stimulation , and to compare the observed networks to the network effect of a BCI neurofeedback modulation of motor cortex activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real EEG-NF | Active comparator | Other: Neurofeedback10 EEG based neurofeedback sessions modulating the activity of the primary motor cortex |
| Sham EEG-NF | Sham comparator | Other: Sham neurofeedback10 sessions of Sham EEG_NF of the motor cortex area |
| Transcrainal Magnetic Stimulation | Active comparator | Device: TMS10 dailt TMS stimulation sessions of M1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 years old, treated medically for neuropathic pain of an upper arm with unsatisfactory results (average daily VAS score over 4)
Key exclusion criteria (5 listed)
- Cognitive decline,
- malignant disease,
- focal neurological deficit,
- illegal substance abuse
- noncompliance with medical therapy or follow up.
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 |
|---|---|---|
| TMSTranscranial magentic stimulation of the motor cortex. Device Details : Model is Magstim TMS Rapid. Manufacturer : MAGSTIM CO LTD. Spring Gardens, Whitland, Carmarthenshire, Wales, U.K., SA34 0HR | Device | Transcrainal Magnetic Stimulation |
| NeurofeedbackEEG neurofeedback based on the primary motor cortex | Other | Real EEG-NF |
| Sham neurofeedbackSham EEG neurofeedback | Other | Sham EEG-NF |
Primary outcome
daily pain levels
Time frame: during three weeks of treatments
daily pain levels will be assessed using a visual assessment score (VAS) during the treament phase (lasting aproximately 3 weeks)
1 secondary outcome
Daily pain measures for one month following the last session
Time frame: one month following the last treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
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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.
Talma Hendler, MD, PhD study director
Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS and Neurofeedback in people with Neuropathic Pain, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 5 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 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Haggai Sharon, MD (972-3-6973953, haggais@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily pain levels (time frame: during three weeks of treatments). 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 21 Mar 2012.