Brain Computer Interface and Virtual Reality (BCI-VR) for Pain Treatment

NCT03889353 | Completed

• 1 other identifier: RC17_0417
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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%

  month 6

Secondary Outcomes (8)

• Evaluate the effectiveness of the BCI intervention on paroxysmal pains

  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

  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

  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

  Day 1, 12, 90, 180

• Evaluate the effect of the intervention on anxiety and depression

  Day 1, 12, 90, 180

Study Arms (1)

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.

Device: BCI sessions

Interventions

BCI sessions DEVICE

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.

BCI sessions

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Fondation Apicil: collaborator

Study Sites (1)

Nantes Uh

Nantes, France

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 26, 2019
• Study Start: May 9, 2019
• Primary Completion: May 9, 2021
• Study Completion: November 9, 2021
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)