Combined Cingulate and Thalamic DBS for Chronic Refractory Chronic Pain

Chronic Refractory Neuropathic Pain Clinical Trial

— EMOPAIN  

Official title:

Treatment of Chronic Refractory Pain by Combined Deep Brain Stimulation of the Anterior Cingulum and Sensory Thalamus: a Feasibility and Safety Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03399942
• Other study ID #: 16-AOIP-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 6, 2018
• Est. completion date: March 20, 2024

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: March 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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,

Related Conditions & MeSH terms

• Chronic Refractory Neuropathic Pain
• Neuralgia

Intervention

Procedure:
• Deep brain Stimulation of cingulum anterior
The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON

Locations

Country	Name	City	State
France	Department of neurosurgery	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of serious adverse events.	description of serious adverse events	Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Primary	Feasibility of ACC-DBS: success the process of surgical intervention	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	Day 0
Primary	Feasibility of ACC-DBS : neurological success of the process of chronic stimulation	neurological success of the process of chronic stimulation will be evaluated by the neurological examination	Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Primary	Feasibility of ACC-DBS : psychiatric success of the process of chronic stimulation	psychiatric success of the process of chronic stimulation will be evaluated by the psychiatric assessment	Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Primary	Feasibility of ACC-DBS : cognitive success of the process of chronic stimulation	cognitive success of the process of chronic stimulation will be evaluated by the cognitive assessment	Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Secondary	Efficacy of ACC-DBS : change of pain intensity	Efficacy of ACC-DBS will be evaluated by pain intensity (VAS)	Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Secondary	Efficacy of ACC-DBS : change of pain intensity	Efficacy of ACC-DBS will be evaluated by pain intensity (Brief Pain Inventory)	Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Secondary	Efficacy of ACC-DBS : change of pain intensity	Efficacy of ACC-DBS will be evaluated by pain intensity (McGill Pain Questionnaire)	Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Secondary	Efficacy of ACC-DBS : change of quality of life by SF-36	Efficacy of ACC-DBS will be evaluated by quality of life (SF36).	Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Secondary	Efficacy of ACC-DBS : change of quality of life by EQ-5D	Efficacy of ACC-DBS will be evaluated by quality of life (EQ5D).	Day 0, Month 1, Month 4, Month 7, Month 10, Month 22