Treatment of Chronic Refractory Pain by Combined Deep Brain Stimulation of the Anterior Cingulum and Sensory Thalamus: a Feasibility and Safety Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Feasibility of ACC-DBS: success the process of surgical intervention
Study Overview
Brief Summary
Deep brain stimulation (DBS) of the sensory thalamus has been proposed for 40 years to treat medically refractory neuropathic pain, but its efficacy remains partial and unpredictable. Recently, bilateral DBS of the dorsal anterior cingulate cortex (ACC), a brain region involved in the integration of the affective and cognitive aspects of pain, has been successively proposed to treat few patients suffering from refractory chronic pain, by decreasing the emotional impact of their chronic pain. ACC-DBS could be an alternative or complementary approach to thalamic DBS in these patients, but the consequences of chronic dACC-DBS on cognition and affects have not been studied specifically.
The primary objective is to evaluate the feasibility and safety of bilateral ACC-DBS combined with unilateral thalamic DBS in patients suffering from chronic unilateral pain, refractory to medical treatment. Secondary objective will evaluate the efficacy of this combined DBS compared to thalamic DBS only.
Detailed Description
Chronic pain represents a major personal and societal burden, especially for medically resistant patients. Deep brain stimulation (DBS) of the sensory thalamus has been proposed for 40 years to treat medically refractory neuropathic pain, but its efficacy remains partial and unpredictable. Recently, bilateral DBS of the dorsal anterior cingulate cortex (ACC), a brain region involved in the integration of the affective, emotional and cognitive aspects of pain, has been successively proposed to treat few patients suffering from refractory chronic pain. In a pilot study, 16 patients treated by ACC-DBS experienced a significant improvement of their quality of life despite a slight decrease of their pain intensity, by improving the affective and emotional impacts of their chronic pain. ACC-DBS could be an alternative or complementary approach to thalamic DBS in these patients. However the consequences of chronic dACC-DBS on cognition and affects have not been studied specifically.
The primary objective of this study is to evaluate the feasibility and safety of bilateral ACC-DBS combined with unilateral thalamic DBS in patients suffering from chronic unilateral pain, refractory to medical treatment. Secondary objective will evaluate the efficacy of this combined DBS compared to thalamic DBS only
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients (age 18-70 years old) suffering from chronic (duration >1 year) unilateral neuropathic pain
- •severe (VAS score >6/10)
- •with high emotional impact (HAD subscores > 10) considered as resistant to medication specific to neuropathic pain at sufficient doses and durations (including at least antiepileptics and antidepressants) and not sufficiently improved by rTMS and relevant surgical solutions.
- •Non inclusion criteria:
- •previous history of stroke,
- •cognitive impairment (MMSE score <24),
- •DSMIV axis I psychiatric disorder,
- •contra-indication to surgery, anesthesia or MRI;
- •patient responder to rTMS,
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility of ACC-DBS: success the process of surgical intervention
Time Frame: Day 0
Feasibility of ACC-DBS will be evaluated by the proportion of patients undergoing with success the process of surgical intervention Safety will be evaluated by neurological examination
Occurence of serious adverse events.
Time Frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
description of serious adverse events
Feasibility of ACC-DBS : neurological success of the process of chronic stimulation
Time Frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
neurological success of the process of chronic stimulation will be evaluated by the neurological examination
Feasibility of ACC-DBS : psychiatric success of the process of chronic stimulation
Time Frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
psychiatric success of the process of chronic stimulation will be evaluated by the psychiatric assessment
Feasibility of ACC-DBS : cognitive success of the process of chronic stimulation
Time Frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
cognitive success of the process of chronic stimulation will be evaluated by the cognitive assessment
Secondary Outcomes
- Efficacy of ACC-DBS : change of quality of life by EQ-5D(Day 0, Month 1, Month 4, Month 7, Month 10, Month 22)
- Efficacy of ACC-DBS : change of quality of life by SF-36(Day 0, Month 1, Month 4, Month 7, Month 10, Month 22)
- Efficacy of ACC-DBS : change of pain intensity(Day 0, Month 1, Month 4, Month 7, Month 10, Month 22)