Transcranial Direct-current Stimulation (tDCS) Efficacy in Refractory Cancer Pain.

NCT04683172 | Unknown

• 2 other identifiers: STIMPAL2020-A2098-31
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Pain is a common symptom in palliative care cancer patients and is often insufficiently relieved. The 2010 INCA report showed that France is not an exception to this worldwide observation (synopsis of the 2010 national survey). This report shows that pain is the symptom that these patients fear the most and that it dramatically impacts their quality of life. These patients may experience nociceptive pain related to stimulation of sensory nerve endings by the tumour. When tumour resection is impossible, a symptomatic analgesic treatment is generally proposed, mainly consisting of administration of opioid analgesics. At high doses, this treatment induces adverse effects, especially drowsiness and psychomotor retardation that impair the patient's quality of life. They may also experience neuropathic pain, secondary to anatomical lesions or functional impairment of nerve structures (peripheral nerves or cerebral or spinal tracts) related to repeated surgical procedures and/or radiotherapy. This type of pain may respond to antiepileptic or antidepressant drugs. At high doses, these treatments also induce adverse effects fairly similar to those observed during treatment of nociceptive pain. As these two types of treatment often need to be coprescribed, these patients frequently present an almost permanent state of drowsiness at the end of life, preventing all normal activities of daily living. In recent years, noninvasive brain stimulation (NIBS) techniques (transcranial magnetic stimulation (rTMS) or transcranial direct-current stimulation (tDCS)) have been successfully used to treat chronic pain. It was shown that these NIBS techniques can improve pain in cancer patients in the palliative care setting.

Conditions

Cancer Pain; Refractory Pain

Outcome Measures

Primary Outcomes (1)

• Mean change in Pain Intensity on the Numerical Rating Scale

  Pain intensity will be scored from 0 to 10 (0=No pain, 10 = worst pain) on the Numerical Rating Scale, 3 times daily. Mean variation of the pain NRS between the baseline assessment (Day -3 to Day -1) and the Day 8 assessment will be calculated and compared between arms.

  Baseline up to Day 8

Secondary Outcomes (9)

• Immediate impact of each tDCS session on pain intensity

  Day 0 up to Day 4

• Response rate at the end of treatment

  Baseline up to Day 8

• Residual analgesic effect

  Baseline up to Day 14

• Residual analgesic effect

  Baseline up to Day 21

• Effects of tDCS on pain

  Baseline up to Day 21

Study Arms (2)

Active tDCS

EXPERIMENTAL

Active tDCS will be delivered daily for 5 consecutive days with the patient either sitting or lying down.A tDCS session generally lasts 20 minutes.

Device: Active Transcranial Direct Current Stimulation

Sham tDCS

SHAM COMPARATOR

Sham tDCS will be delivered daily for 5 consecutive days with the patient either sitting or lying down.A tDCS session generally lasts 20 minutes.

Device: Sham Transcranial Direct Current Stimulation

Interventions

Active Transcranial Direct Current Stimulation DEVICE

tDCS consists of delivering a low-intensity (1 to 2 milliamperes) direct electrical current by means of a pair of electrodes (anode and cathode) applied to the scalp. Electrodes generally have a diameter (round electrode) or a diagonal (rectangular electrodes) ranging from 2 to 3.5 cm. To stimulate a given cortical zone, the anode is placed over of the selected zone, generally identified by means of an EEG headset (10/20 System Positioning). For the treatment of pain, the anode is placed over the primary motor cortex (M1) on the contralateral side to the pain or on the left side in patients with diffuse pain. The cathode is placed over a supposedly neutral cortical zone, usually the contralateral supraorbital cortex with respect to the anode. In this study, the stimulation intensity will be 1.5 mA using round sponge electrodes 3.5 cm in diameter.

Also known as: Active tDCS

Active tDCS

Sham Transcranial Direct Current Stimulation DEVICE

The tDCS device has a "Sham" mode that allows for true placebo stimulation. A simulated session is thus designed as a real stimulation session without its effects. Sensations similar to tDCS are created by generating currents only at the start of the session. Same modalities as for the Active tDCS procedure will therefore be put in place: a pair of electrodes (anode and cathode) are applied to the scalp.To stimulate a given cortical zone, the anode is placed over of the selected zone, generally identified by means of an EEG headset (10/20 System Positioning). For the treatment of pain, the anode is placed over the primary motor cortex (M1) on the contralateral side to the pain or on the left side in patients with diffuse pain. The cathode is placed over a supposedly neutral cortical zone, usually the contralateral supraorbital cortex with respect to the anode.

Also known as: Sham tDCS

Sham tDCS

Eligibility Criteria

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

You may qualify if:

• Patient with a confirmed cancer at a palliative stage
• Pain present on a daily or almost daily basis (at least 4 days out of 7)
• Patients aged 18 or over
• Patients who can be followed for the duration of the study (i.e. 3 weeks)
• Patients affiliated to a health insurance plan or entitled
• Life expectancy estimated at more than 3 weeks
• Agreeing to participate in the study and having signed an informed consent

You may not qualify if:

• Inability to self-assess pain and complete self-questionnaires
• History of head trauma or neurosurgical injury
• Symptomatic intracranial hypertension (HTIC)
• Uncontrolled epilepsy
• Impossibility to correctly positioning the medical device
• Abuse of drugs or psychoactive substances, at the discretion of the investigator
• Current major depression or psychosis
• Pregnant or breastfeeding woman
• Patient already included in a research protocol on pain
• Patient under legal protection
• Absence of affiliation to a social security scheme
• Specific contraindication to tDCS (intracerebral metal implant)
• Patients deprived of liberty
• Patients undergoing psychiatric care.

Sponsors & Collaborators

• Elsan: lead

Study Sites (2)

Clinique Brétéché

Nantes, 44000, France

RECRUITING

CHU Nantes

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

Cancer Pain; Pain, Intractable

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Paul NGUYEN, MD

  Clinique Brétéché - Nantes

  STUDY DIRECTOR

Central Study Contacts

Shahnaz KLOUCHE, MD

CONTACT

(0)1 58 56 41 71; klouche@elsan.care

Marine ROYER

CONTACT

royer@elsan.care

Study Design

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

Model Details: Bicentre, double blinded, randomized, parallel-arm, sham-controlled trial

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: May 15, 2021
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)