Combined Cingulate and Thalamic DBS for Chronic Refractory Chronic Pain

NCT03399942 | Completed

• 1 other identifier: 16-AOIP-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Refractory Neuropathic Pain

Outcome Measures

Primary Outcomes (5)

• Occurence of serious adverse events.

  description of serious adverse events

  Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

• 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

• 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

• 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

• 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 Outcomes (5)

• Efficacy of ACC-DBS : change of pain intensity

  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

• Efficacy of ACC-DBS : change of pain intensity

  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 quality of life by EQ-5D

  Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

Study Arms (2)

DBS-ACC ON

EXPERIMENTAL

Start of stimulation of the DBS-ACC: On the first period, between M4 and M7, the DBS-ACC is ON and the second period, between M7 and M10 is OFF

Procedure: Deep brain Stimulation of cingulum anterior

DBS-ACC OFF

EXPERIMENTAL

Start of stimulation of the DBS-ACC: On the first period, between M4 and M7, the DBS-ACC is OFF and the second period, between M7 and M10 is ON

Procedure: Deep brain Stimulation of cingulum anterior

Interventions

Deep brain Stimulation of cingulum anterior PROCEDURE

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

DBS-ACC OFF; DBS-ACC ON

Eligibility Criteria

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

You may qualify if:

• 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.
• 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,

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Department of neurosurgery

Nice, 06000, France

Location

Related Publications (2)

• Fontaine D, Leplus A, Donnet A, Darmon N, Balossier A, Giordana B, Simonet B, Isan P, Regis J, Lanteri-Minet M. Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study. J Headache Pain. 2025 Feb 17;26(1):35. doi: 10.1186/s10194-025-01967-8.

  PMID: 39962366 BACKGROUND

• Leplus A, Isan P, Balossier A, Mouffok S, Donnet A, Papadopoulo T, Lanteri-Minet M, Regis J, Fontaine D. Somatotopy of the sensory thalamus: inputs from directional deep brain stimulation in pain patients. Ann Clin Transl Neurol. 2024 Jun;11(6):1502-1513. doi: 10.1002/acn3.52067. Epub 2024 Apr 26.

  PMID: 38668642 RESULT

Study Officials

• Denys FONTAINE

  fontaine.d@chu-nice.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: January 17, 2018
• Study Start: April 6, 2018
• Primary Completion: April 17, 2023
• Study Completion: October 2, 2024
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

FR (1)