Cancer PainSTIMPALNCT04683172
Transcranial Direct-current Stimulation (tDCS) Efficacy in Refractory Cancer Pain.
A study testing Active Transcranial Direct Current Stimulation in people with Cancer Pain and Refractory Pain, run by Elsan at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Refractory Pain
- What is being tested?
- Active Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 15 May 2021to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a confirmed cancer at a palliative stage
- Pain whose mean intensity is greater than or equal to 4/10 in the 48 hours preceding inclusion
- Pain present on a daily or almost daily basis (at least 4 days out of 7)
- Pain that has been present for at least 48 hours before inclusion
- Patients aged 18 or over
- Patients who can be followed for the duration of the study (i.e. 3 weeks)
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Marine ROYER contact
France2 sites, 2 recruiting
- Recruiting
Clinique Brétéché
Nantes, 44000
Jean-Paul NGUYEN, MD
- Recruiting
CHU Nantes
Nantes, 44093
Hélène GAILLARD-PERERA, MD
About this study
Official title: Efficacy Assessment of Transcranial Direct Current STIMulation (tDCS) in Reducing Pain in PALliative Cancer Patients.
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.
Read the detailed description
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.
- Conditions
- Cancer Pain, Refractory Pain
- Being tested
- Active Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
- Medical subject headings
- Cancer Pain, Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Direct Current StimulationDevice
Also called Active tDCS
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.
Sham Transcranial Direct Current StimulationDevice
Also called Sham 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Day 8
Secondary outcomes (9)
Immediate impact of each tDCS session on pain intensity
Change in Pain Numerical Rating Scale score measured before and after each tDCS session.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Day 21
Analgesic treatments consumption
Medication Quantification Scale (MQS). Mean variations of scores will be compared between arms.
Measured: Baseline up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start15 May 2021
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Bicentre, double blinded, randomized, parallel-arm, sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul NGUYEN, MD, Study director, Clinique Brétéché - Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683172
- Sponsor's protocol ID
- STIMPAL
- Other IDs
- 2020-A2098-31
- Acronym
- STIMPAL
- Status last verified
- Sep 2023
- First submitted
- 21 Dec 2020
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Assessment of Transcranial Direct Current STIMulation (tDCS) in Reducing Pain in PALliative Cancer Patients.
- ClinicalTrials.gov ID
- NCT04683172
- Acronym / sponsor ID
- STIMPAL / STIMPAL
- Conditions
- Cancer Pain, Refractory Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Bicentre, double blinded, randomized, parallel-arm, sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active Transcranial Direct Current StimulationActive tDCS will be delivered daily for 5 consecutive days with the patient either sitting or lying down.A tDCS session generally lasts 20 minutes. |
| Sham tDCS | Sham comparator | Device: Sham Transcranial Direct Current StimulationSham tDCS will be delivered daily for 5 consecutive days with the patient either sitting or lying down.A tDCS session generally lasts 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with a confirmed cancer at a palliative stage
- Pain whose mean intensity is greater than or equal to 4/10 in the 48 hours preceding inclusion
- Pain present on a daily or almost daily basis (at least 4 days out of 7)
- Pain that has been present for at least 48 hours before inclusion
- Patients aged 18 or over
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Transcranial Direct Current StimulationAlso: Active tDCStDCS 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. | Device | Active tDCS |
| Sham Transcranial Direct Current StimulationAlso: Sham tDCSThe 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. | Device | Sham tDCS |
Primary outcome
Mean change in Pain Intensity on the Numerical Rating Scale
Time frame: Baseline up to Day 8
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.
9 secondary outcomes
Immediate impact of each tDCS session on pain intensity
Time frame: Day 0 up to Day 4
Response rate at the end of treatment
Time frame: Baseline up to Day 8
Residual analgesic effect
Time frame: Baseline up to Day 14
Residual analgesic effect
Time frame: Baseline up to Day 21
Effects of tDCS on pain
Time frame: Baseline up to Day 21
Effects of tDCS on general symptoms
Time frame: Baseline up to Day 21
Effects of tDCS on anxiety and depression
Time frame: Baseline up to Day 21
Effects of tDCS on anxiety
Time frame: Baseline up to Day 21
Analgesic treatments consumption
Time frame: Baseline up to Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marine ROYER contact
Jean-Paul NGUYEN, MD study director
Clinique Brétéché - Nantes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Direct Current Stimulation in people with Cancer Pain and Refractory Pain, run by Elsan at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahnaz KLOUCHE, MD ((0)1 58 56 41 71 ext. +33, klouche@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Pain Intensity on the Numerical Rating Scale (time frame: Baseline up to Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.