Neuropathic PainGHOSTNCT03889353
Brain Computer Interface and Virtual Reality (BCI-VR) for Pain Treatment
A study testing BCI sessions in people with Neuropathic Pain, run by Nantes University Hospital at 1 site in France.
Trial summary
Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- BCI sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2019to 9 Nov 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neuropathic pain / Phantom limb pain
- Mean pain score >3 centimeter
- Permanent pain
- If Plexus Brachial injury : > 6 month
- If Amputation : at least at wrist level
- Motor and Sensory deficit : complete or incomplete
- Informed consent
- Public Health Insurance
Who cannot join
- MRI contraindication
- Subject included in another interventional study
- Pregnant women
- Majors under guardianship or curatorship or safeguard of justice
- History of associated head injury or any other neurological pathology altering the sensorimotor cerebral system or cognitive abilities and higher functions.
- Presence of other lesions of the peripheral nervous system that may induce associated neuropathic pain.
- Head trauma associated altering somatosensory system or cognitive abilities and higher functions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Mental Motor Imagery Training Using "GHOST", a Novel BCI-VR Feedback System (Brain Computer Interface and Virtual Reality) Efficient and Safe for Pain Relief in Phantom Limb Pain After Upper Limb Amputation or Brachial Plexus Lesion
Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device.
Read the detailed description
Upper limb's phantom pain, due to amputation or to injury of the brachial plexus are possibly due to maladaptive CNS (central nervous system facility) plasticity and thus could be decreased by retraining the sensorimotor cortex using Mental Motor Imaging guided through a novel BCI-RV feedback system : "Ghost". The aim of this study is to evaluate safety and efficacy of this BCI pain treatment developed by our team.
- Conditions
- Neuropathic Pain
- Being tested
- BCI sessions
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI sessionsDevice
up to 3 test sessions (D-30) to eliminate BCI illiteracy, then 10 rehabilitation sessions of 90 minutes (D1-D5 and D8-D12) - Session content : Guided training - Control of an avatar (VR, first person view) of the affected limb by motor mental imagery decoded by a brain computer interface.
| Study group | Role | What they receive |
|---|---|---|
| BCI sessions | Experimental | up to 3 test sessions (Day-30) to eliminate BCI illiteracy, then 10 rehabilitation sessions of 90 minutes (Day 1-Day 5 and Day 8-Day 12) - Session content : Guided training - Control of an avatar (VR, first person view) of the affected limb by motor mental imagery decoded by a brain computer interface. Receives: Device: BCI sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of BCI intervention on mean daily pain
Determination by curve fitting technique (regression analysis) of the peak effect and calculation of the rate of improvement: success if> 30%
Measured: month 6
Secondary outcomes (8)
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
duration of the paroxysmal pains
Measured: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
the intensity of paroxysmal pains This scale measures the intensity of paroxysmal pain. It is a self-assessment. Scores measured with Visual Analog Score.
The scale is graded from 0 (no pain) to 10 (most intense pain the patient can imagine).
The value 10 (maximum) is the worst result. There is no combination of sub-ranges to compute the score
Measured: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
the frequency of paroxysmal pains
Measured: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6
Evaluate the effect of the intervention on quality of life: SF36
SF36 Questionnaire quality of life For each question, an algorithm allows the calculation of scores to obtain a number between 0 (zero quality - worse outcome) and 100 (maximum quality).
Measured: Day 1, 12, 90, 180
Evaluate the effect of the intervention on anxiety and depression
HAD questionnaire : Hospital Anxiety and Depression scale It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), resulting in two scores (maximum score of each score = 21).
To detect anxious and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D):
- 7 or less: lack of symptomatology
- 8 to 10: doubtful symptomatology - 11 and more: definite symptomatology.
Measured: Day 1, 12, 90, 180
evaluating cortical plasticity
MRI analysis the physiopathological mechanisms governing phantom pain
Measured: Day 1, 12, 30
evaluating cortical plasticity
EEG analysis the physiopathological mechanisms governing phantom pain
Measured: Day 1, 12, 30
Evaluate the performance of subjects to control the neurofeedback system
Motor Imagery Questionnaire
Measured: Day 1, 12, 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start9 May 2019
- Primary completion9 May 2021
- Study completion9 Nov 2021
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889353
- Sponsor's protocol ID
- RC17_0417
- Acronym
- GHOST
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2019
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Mental Motor Imagery Training Using "GHOST", a Novel BCI-VR Feedback System (Brain Computer Interface and Virtual Reality) Efficient and Safe for Pain Relief in Phantom Limb Pain After Upper Limb Amputation or Brachial Plexus Lesion
- ClinicalTrials.gov ID
- NCT03889353
- Acronym / sponsor ID
- GHOST / RC17_0417
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- 9 May 2019 (actual)
- Primary completion
- 9 May 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 26 Mar 2019 (actual)
- 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.
Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device.
Detailed description
Upper limb's phantom pain, due to amputation or to injury of the brachial plexus are possibly due to maladaptive CNS (central nervous system facility) plasticity and thus could be decreased by retraining the sensorimotor cortex using Mental Motor Imaging guided through a novel BCI-RV feedback system : "Ghost". The aim of this study is to evaluate safety and efficacy of this BCI pain treatment developed by our team.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCI sessions | Experimental | Device: BCI sessionsup to 3 test sessions (Day-30) to eliminate BCI illiteracy, then 10 rehabilitation sessions of 90 minutes (Day 1-Day 5 and Day 8-Day 12) - Session content : Guided training - Control of an avatar (VR, first person view) of the affected limb by motor mental imagery decoded by a brain computer interface. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Neuropathic pain / Phantom limb pain
- Mean pain score >3 centimeter
- Permanent pain
- If Plexus Brachial injury : > 6 month
- If Amputation : at least at wrist level
Key exclusion criteria (7 listed)
- MRI contraindication
- Subject included in another interventional study
- Pregnant women
- Majors under guardianship or curatorship or safeguard of justice
- History of associated head injury or any other neurological pathology altering the sensorimotor cerebral system or cognitive abilities and higher functions.
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 |
|---|---|---|
| BCI sessionsup to 3 test sessions (D-30) to eliminate BCI illiteracy, then 10 rehabilitation sessions of 90 minutes (D1-D5 and D8-D12) - Session content : Guided training - Control of an avatar (VR, first person view) of the affected limb by motor mental imagery decoded by a brain computer interface. | Device | BCI sessions |
Primary outcome
Efficacy of BCI intervention on mean daily pain
Time frame: month 6
Determination by curve fitting technique (regression analysis) of the peak effect and calculation of the rate of improvement: success if> 30%
8 secondary outcomes
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
Time frame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
Time frame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
Time frame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6
Evaluate the effect of the intervention on quality of life: SF36
Time frame: Day 1, 12, 90, 180
Evaluate the effect of the intervention on anxiety and depression
Time frame: Day 1, 12, 90, 180
evaluating cortical plasticity
Time frame: Day 1, 12, 30
evaluating cortical plasticity
Time frame: Day 1, 12, 30
Evaluate the performance of subjects to control the neurofeedback system
Time frame: Day 1, 12, 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Neuropathic Pain
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingPhase 2
Ultra-Early Gamma Knife Stereotactic Radiosurgery for TN
Trigeminal Neuralgia (TN)
RecruitingPhase 1/2
RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia
Trigeminal Neuralgia
RecruitingPhase 2
Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND)
Treatment Resistant Depression, Chronic Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI sessions in people with Neuropathic Pain, run by Nantes University Hospital at 1 site in France.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 21 Apr 2022. 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 France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of BCI intervention on mean daily pain (time frame: month 6). 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 Apr 2022.