An interventional study of Active Transcranial Direct Current Stimulation and Sham Transcranial Direct Current Stimulation in Cancer Pain and Refractory Pain, sponsored by Elsan. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Elsan · Not applicable, Interventional, and Supportive care
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.
tDCS appears to be more suitable than rTMS for the treatment of palliative care patients, who are often difficult to mobilize, as tDCS can be delivered at the patient's bedside and possibly even at home, which is not the case with rTMS. tDCS also appears to be rapidly effective (after 5 sessions) in the context of cancer pain, and this effect lasts longer than that of rTMS.
The proposed treatment of refractory cancer pain by tDCS in palliative care patients is a new treatment modality that is well adapted to hospitalised patients. Each patient will receive 20 minutes of transcranial direct-current stimulation daily for 5 consecutive days.
One arm will receive active stimulation and the control arm will receive sham stimulation. Patients and investigators will be blinded to the type of tDCS.
By improving the patient's activities of daily living, this treatment will enable the patient to return home under good conditions for both the patient and the caregivers. This treatment can also be continued at home. This strategy is consistent with current guidelines in this field, in which the priorities are improvement of quality of life, return home and decreased workload for caregivers.
310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.
This study's planned enrollment of 70 is above the median of 62 across 235 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Elsan is the lead sponsor of 68 studies on the registry; 35 are open to participants now.
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Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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
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
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.
Time frame: Baseline up to Day 8
Immediate impact of each tDCS session on pain intensity
Change in Pain Numerical Rating Scale score measured before and after each tDCS session.
Time frame: Day 0 up to Day 4
Response rate at the end of treatment
Efficacy of treatment, defined by a ≥ 20% reduction of the mean Numerical Rating Scale score between Baseline and Day 8.
Time frame: Baseline up to Day 8
Residual analgesic effect
Pain Numerical Rating Scale scores will be measured 3 times daily. Mean Numerical Rating Scale score will be calculated and compared between arms.
Time frame: Baseline up to Day 14
Residual analgesic effect
Pain Numerical Rating Scale scores will be measured 3 times daily. Mean Numerical Rating Scale score will be calculated and compared between arms.
Time frame: Baseline up to Day 21
Effects of tDCS on pain
Brief Pain Inventory questionnaire, short form (BPI). Mean variations of scores will be compared between arms.
Time frame: Baseline up to Day 21
Effects of tDCS on general symptoms
Edmonton Symptom Assessment System (ESAS). Mean variations of scores will be compared between arms.
Time frame: Baseline up to Day 21
Effects of tDCS on anxiety and depression
Hospital Anxiety and Depression Scale (HADS). Mean variations of scores will be compared between arms.
Time frame: Baseline up to Day 21
Effects of tDCS on anxiety
(State-Trait Anxiety Inventory (Form Y) (STAI-Y). Mean variations of scores will be compared between arms.
Time frame: Baseline up to Day 21
Analgesic treatments consumption
Medication Quantification Scale (MQS). Mean variations of scores will be compared between arms.
Time frame: Baseline up to Day 8
Plan to share: No
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