Posterior-superior Insula Deep Brain Stimulation in Refractory Peripheral Neuropathic Pain Patients

NCT04279548 | Completed DMC FDA Device

• 1 other identifier: PSI-DBS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the long term pain relief after deep brain stimulation on posterior-superior insula (PSI) in patients with refractory peripheral neuropathic pain who responded to real but not to sham non-invasive stimulation by deep repetitive transcranial magnetic stimulation - PSI-drTMS.

Conditions

Neuropathic Pain; Neuropathy;Peripheral

Keywords

Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Response (>30% pain intensity reduction) after ON but not OFF stimulation periods.

  Pain intensity measured on a Numeric Rating Scale (0-10) where 0 is no pain and 10 is the worst pain imaginable

  after 3 months in the ON / OFF conditions

Secondary Outcomes (2)

• % of patients with anxiety and depression

  baseline, 3 months and 15 months after the intervention

• Incidence of symptoms of neuropathic pain

  baseline, 3 months and 15 months after the intervention

Other Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events as assessed by self reported

  baseline, 3 months and 15 months after the intervention

• Quality of life related to pain relief

  baseline, 3 months and 15 months after the intervention

Study Arms (2)

On DBS

ACTIVE COMPARATOR

Patients in the on mode DBS

Device: Deep Brain Stimulation

Off DBS

SHAM COMPARATOR

Patients in the off mode DBS

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Patients will have a stimulation electrode inserted neurosurgically by neuronavigation to the PSI, on the target used for drTMS, on the insula contralateral to the pain side. After surgery will be randomized to be in in either the ON or OFF DBS

Off DBS; On DBS

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and non-pregnant women aged 21-70 years.
• Ability to give informed consent in accordance with institutional policy.
• Have a diagnosis of neuropathic pain according to Douleur neuropathique 4 questions (DN4).
• Patients with predominant pain on the face and upper extremities in relation to the lower limbs. In this study, predominance will be defined as the difference of ≥ 30% or ≥ 2 points on the VAS scale between upper limb / face pain and lower limb pain.
• Pain lasting more than 12 months.
• Documented resistance to clinical treatment, defined in this study as persistence of pain after a minimum of 2 appropriate pharmacological treatments, including at least one antidepressant / anticonvulsant and / or gabapentins. Adequacy of treatments will be defined by the use of drugs in doses considered adequate in the literature or below the threshold of side effects.
• Visual analog scale (EVA) scores of at least four during initial assessments.
• No change in the analgesic medication regimen for chronic neuropathic pain during the 4 weeks preceding entry into the study.
• Ability to comply with the tests and follow-up defined by the study protocol;
• Absence of routine contraindications to the surgical procedure (eg Coagulopathies, blood dyscrasias). These will be evaluated by members of the neurosurgical team responsible for the study

You may not qualify if:

• Alcohol abuse, medication, or addiction to illicit substances in the last 12 months.
• Diagnosis of idiopathic trigeminal neuralgia or atypical facial pain.
• Advanced cardiovascular disease stage that makes anesthesia and surgery unsafe, as determined by the neurosurgeon / clinical team.
• Clinically relevant lesions (tumor, for example) on preoperative magnetic resonance imaging.
• Cardiac pacemaker / implanted defibrillator or other active stimulators.
• Medical condition that requires repeated resonances.
• Patients using chemotherapy for the treatment of malignant tumors or who need chronic oral or intravenous treatment with immunosuppressants or steroids.
• Patients unable to comply with the study visit schedule.
• Brain ablative surgery or previous neurosurgery that prevents or increases the risk of implantation of the electrodes.
• Patients of childbearing potential or infants with a positive pregnancy test or without the use of adequate contraception.
• Other medical conditions that require probable hospitalization during the study.
• History of epilepsy or status epilepticus.
• Chronic infection.
• Diagnosis of fibromyalgia.
• Plans for using diathermy in the future.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-900, Brazil

Location

Related Publications (1)

• Dongyang L, Cunha PHM, Lapa JDS, Kubota GT, Junior JR, Fernandes AM, Thibes RB, Pinheiro DS, Iglesio RF, Duarte KP, Sato J, da Silva VA, Lucato LT, Figueiredo EG, Carlotti Junior CG, Yeng LT, Teixeira MJ, de Andrade DC. Insula Deep Brain Stimulation for Neuropathic Pain: A Cross-Over, Randomized, Sham-Controlled Trial. Neuromodulation. 2025 Aug 18:S1094-7159(25)00261-2. doi: 10.1016/j.neurom.2025.07.001. Online ahead of print.

  PMID: 40824225 DERIVED

MeSH Terms

Conditions

Neuralgia; Neuritis

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 21, 2020
• Study Start: January 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: July 1, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion

Locations

BR (1)