Chronic PainONCOSTIMNCT07912775
Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors
A study testing Active tDCS with Sternberg task in people with Chronic Pain and Neuropathic Pain, run by Instituto de investigación e innovación biomédica de Cádiz at 2 sites in Spain.
Trial summary
The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) combined with a working-memory task can treat chronic pain and related emotional and cognitive problems after chemotherapy in adult cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Neuropathic Pain, Cancer Survivors
- What is being tested?
- Active tDCS with Sternberg task
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of breast, prostate, lung, or colorectal cancer.
- Presence of chronic pain related to the cancer or its treatment, with a DN4 score ≥ 4
- Refractory to medical treatment for at least two months.
- Completion of systemic chemotherapy.
- Age ≥ 18 years.
- Ability to read, write, and understand the study questionnaires.
Who cannot join
- Relevant psychiatric or neurological disorders, such as dementia, psychosis, or epilepsy.
- Concomitant disabling medical conditions.
- Intracranial metallic implants or pacemakers.
- Extensive myocardial ischemia.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Puerta del Mar University Hospital
Cadiz, Cádiz
Javier Jaén Olasolo, +34 956 002 698, javier.jaen.sspa@juntadeandalucia.es
Jerez de la Frontera University Hospital
Jerez de la Frontera, Cadiz
Javier Jaén Olasolo, +34 956 002 698, javier.jaen.sspa@juntadeandalucia.es
María A Moreno-Santos, mariaa.moreno.santos.sspa@juntadeandalucia.es
About this study
Official title: Leveraging the Therapeutic Benefits of Transcranial Direct Current Stimulation to Treat Chemotherapy-related Chronic Pain and Psycho-cognitive Comorbidities in Cancer Survivors
The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) combined with a working-memory task can treat chronic pain and related emotional and cognitive problems after chemotherapy in adult cancer survivors. tDCS is a non-invasive and painless technique that uses a very weak electrical current, applied through two small electrodes on the head, to modulate the activity of certain brain areas. The main questions it aims to answer are:
- Does tDCS reduce chronic pain intensity after chemotherapy in cancer survivors?
- Does tDCS also reduce anxiety, depression, and cognitive problems, and improve the regulation of cortisol, a stress-related hormone?
- Are the effects on pain, anxiety, depression, cognitive problems, and cortisol sustained when treatment continues with a maintenance phase of up to 2 months?
Read more
Researchers will compare real tDCS to sham (placebo) tDCS, a look-alike procedure that does not deliver effective stimulation, to see if real tDCS works to reduce pain and improve these symptoms.
Participants will:
- Receive real or sham tDCS (assigned by chance) in 5 daily sessions over 1 week. Each session lasts 20 minutes: 10 minutes at rest and 10 minutes while doing a working-memory task
- If they did not respond to sham tDCS, be offered 5 additional daily sessions of real tDCS
- If they respond to treatment, continue with real tDCS twice a week for up to 2 months
- Complete assessments of pain, mood, memory, attention, and quality of life before treatment, after each phase, and during and at the end of the maintenance phase
- Collect saliva samples to measure cortisol
Read the detailed description
Background and rationale. Chronic pain affects a large proportion of cancer survivors and is often accompanied by anxiety, depression, and cognitive impairment after chemotherapy. Current treatments rely heavily on opioids, which have significant side effects. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has shown analgesic effects in some cancer populations, but evidence in cancer survivors, beyond breast cancer, is scarce. This study evaluates tDCS combined with a working-memory task as an adjuvant treatment for chronic pain after chemotherapy and its associated psycho-cognitive comorbidities, both in the short term (acute phase) and over a maintenance period of up to 2 months.
Study design. This is a randomized, double-blind, sham-controlled, parallel-group clinical trial in the acute phase, followed by an open-label crossover phase for non-responders who received sham, and an open-label maintenance phase with active tDCS for responders. It is conducted at university hospitals in the province of Cádiz, Spain. Participants are randomly assigned to active or sham tDCS using a computer-generated randomization sequence kept by independent personnel. Neither participants nor the staff delivering the intervention know the assigned condition during the acute phase.
Procedures. Phase I (acute, double-blind): participants receive 5 consecutive daily sessions (one week) of active or sham tDCS. Stimulation is delivered with a battery-driven constant-current stimulator (Nurostym tES, CE-marked) through two saline-soaked sponge electrodes, with the anode over the primary motor cortex (C3/C4, 10-20 system, contralateral to the most affected side) and the cathode over the contralateral supraorbital region. Active stimulation consists of 2 mA for 20 minutes, with 30-second ramp-up and ramp-down. In sham stimulation, current is applied only briefly at the beginning and end of the session to mimic the sensation of active stimulation. During each 20-minute session, in both conditions, participants receive stimulation at rest for the first 10 minutes and perform the Sternberg working-memory task during the following 10 minutes. At the end of the acute phase, participants are asked which condition they believe they received, to check the integrity of blinding.
Phase II (open-label crossover): participants who received sham tDCS and did not respond receive 5 additional consecutive daily sessions of active tDCS.
Phase III (maintenance, open-label): participants who respond to treatment, defined as a reduction of at least 2 points in pain intensity on the visual analogue scale (VAS) relative to baseline at the end of the acute phase or the crossover phase, receive two sessions of active tDCS per week for up to 2 months as an add-on to standard care, following the same stimulation and task scheme.
Assessments. Assessments are performed at baseline (T0), after the acute phase (T1), after the crossover phase when applicable (T2), one month into the maintenance phase (T3), and at the end of the maintenance phase (T4). Pain intensity, anxiety, depression, cognitive function, quality of life, and diurnal salivary cortisol are assessed at baseline and reassessed after the acute and crossover phases and during and at the end of maintenance, to determine whether the effects of tDCS are sustained over time. Cortisol is collected at home on two consecutive days and analyzed by commercial immunoassay. Samples are coded, used only for research purposes, and processed in duplicate by the research unit. Safety is monitored continuously during each session and at the scheduled visits, with adverse events recorded in the case report form.
Statistical analysis. Sample size was calculated for an expected between-group difference of 2 points in pain intensity (95% confidence, 80% power), giving 25 participants per group, increased to 60 in total to account for attrition. The main analysis follows the intention-to-treat principle. Groups and time points are compared with ANOVA and MANOVA with post hoc corrections. Regression, mediation, moderation, and path analyses will explore the role of cortisol and of clinical variables, including sex, in the response to tDCS.
- Conditions
- Chronic Pain, Neuropathic Pain, Cancer Survivors, Anxiety, Depression, Cognitive Dysfunction
- Being tested
- Active tDCS with Sternberg task, Sham tDCS with Sternberg task
- Keywords
- Transcranial Direct Current Stimulation, tDCS, Noninvasive Brain Stimulation, Neuromodulation, Chemotherapy, Cancer Survivorship, Primary Motor Cortex, Salivary Cortisol, Chronic Pain
- Medical subject headings
- Chronic Pain, Neuralgia, Anxiety Disorders, Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS with Sternberg taskDevice
Also called tDCS, Nurostym tES
Nurostym tES stimulator (Neuro Device Group SA, Poland; CE-marked) with two saline-soaked sponge electrodes. Anode over the primary motor cortex (C3/C4, 10-20 system, contralateral to the most affected side), cathode over the contralateral supraorbital region. 2 mA for 20 minutes with 30-second ramp-up and ramp-down. During each session, the first 10 minutes are at rest and the next 10 minutes are while performing the Sternberg working-memory task. Acute phase and crossover: 5 consecutive daily sessions. Maintenance: 2 sessions per week for up to 2 months.
Sham tDCS with Sternberg taskDevice
Also called Sham stimulation, Sham tDCS, Nurostym tES (sham mode)
Same device, electrode placement, and session schedule as active tDCS, with current delivered only during the 30-second ramp-up and ramp-down at the beginning and end of the session to mimic the sensation of active stimulation, without sustained stimulation. Participants also perform the Sternberg working-memory task (10 minutes at rest, then 10 minutes performing the task). 5 consecutive daily sessions in the acute phase.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Phase I (acute, double-blind): 5 consecutive daily sessions of active tDCS (2 mA, 20 minutes, 30-second ramp-up and ramp-down) combined with the Sternberg working-memory task (10 minutes at rest, then 10 minutes performing the task). Responders (at least 2-point reduction on the pain VAS from baseline) continue to Phase III (maintenance, open-label): active tDCS with the same scheme twice a week for up to 2 months. Receives: Device: Active tDCS with Sternberg task |
| Sham tDCS | Sham comparator | Phase I (acute, double-blind): 5 consecutive daily sessions of sham tDCS (brief ramp-up and ramp-down at the beginning and end of the session, without sustained stimulation) combined with the Sternberg working-memory task (10 minutes at rest, then 10 minutes performing the task). Non-responders then receive Phase II (open-label crossover): 5 consecutive daily sessions of active tDCS. Responders, after Phase I or Phase II, continue to Phase III (maintenance, open-label): active tDCS twice a week for up to 2 months. Receives: Device: Sham tDCS with Sternberg task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity (Visual Analogue Scale, VAS) after the acute phase
Change from baseline in pain intensity measured with the Visual Analogue Scale (VAS), comparing active tDCS with sham tDCS. Scores range from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate a worse outcome. Responders are defined as participants with a reduction of at least 2 points from baseline.
Measured: Baseline (T0) and after the acute phase at 1 week (T1)
Secondary outcomes (10)
Change in pain intensity (Visual Analogue Scale, VAS) from the end of the acute phase through maintenance
Change in pain intensity measured with the Visual Analogue Scale (VAS), relative to baseline, from the end of the acute phase through the end of maintenance (assessed at T2, T3, and T4). Scores range from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate a worse outcome.
Measured: From the end of the acute phase at 1 week (T1) to the end of maintenance at up to 2 months (T4)
Change in pain severity and interference (Brief Pain Inventory, BPI)
Change from baseline in pain severity and pain interference with daily functioning measured with the Brief Pain Inventory - Short Form (BPI-SF). The severity score (mean of 4 items) and the interference score (mean of 7 items) each range from 0 to 10; higher scores indicate greater severity and interference (worse outcome).
Measured: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
Change from baseline in anxiety and depression symptoms, measured with the 14-item Hospital Anxiety and Depression Scale (HADS). The anxiety and depression subscales each range from 0 to 21; higher scores indicate more severe symptoms (worse outcome).
Measured: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in global cognitive function (Montreal Cognitive Assessment, Spanish version, MoCA-S)
Change from baseline in global cognitive function, measured with the Spanish version of the Montreal Cognitive Assessment (MoCA-S). Total scores range from 0 to 30; higher scores indicate better cognitive function (better outcome).
Measured: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in information processing speed (Symbol Digit Modalities Test, SDMT)
Change from baseline in information processing speed and attention measured with the written Symbol Digit Modalities Test (SDMT), scored as the number of correct responses in 90 seconds. Scores range from 0 to 110; higher scores indicate better performance (better outcome).
Measured: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in sustained attention and working memory (Paced Auditory Serial Addition Test, PASAT-3)
Change from baseline in sustained and divided attention and working memory measured with the 3-second version of the Paced Auditory Serial Addition Test (PASAT-3), scored as the number of correct responses. Scores range from 0 to 60; higher scores indicate better performance (better outcome).
Measured: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in verbal fluency (Controlled Oral Word Association Test, COWAT)
Change from baseline in executive function and semantic and phonemic verbal fluency measured with the Controlled Oral Word Association Test (COWAT), scored as the total number of correct words generated (60 seconds per letter or category). The minimum score is 0 and there is no fixed maximum; higher scores indicate better performance (better outcome).
Measured: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in verbal learning and memory (Rey Auditory Verbal Learning Test, RAVLT)
Change from baseline in verbal learning and short- and long-term auditory-verbal memory measured with the Rey Auditory Verbal Learning Test (RAVLT). Total learning across trials 1-5 ranges from 0 to 75; immediate (post-interference) and delayed recall each range from 0 to 15; higher scores indicate better performance (better outcome).
Measured: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in quality of life (World Health Organization Quality of Life - Brief Version, WHOQOL-BREF)
Change from baseline in quality of life measured with the 26-item World Health Organization Quality of Life - Brief Version (WHOQOL-BREF). Physical, psychological, social relationships and environment domain scores are transformed to a 0-100 scale; higher scores indicate better quality of life (better outcome).
Measured: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in diurnal salivary cortisol
Change from baseline in diurnal salivary cortisol, measured in saliva samples collected on two consecutive days and analyzed in duplicate by immunoassay. Mean values of the samples taken at the same time of day on both days are used. Concentrations are expressed in nmol/L.
Measured: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel-group, sham-controlled acute phase (Phase I: 5 daily sessions over 1 week) with two arms: active tDCS and sham tDCS. It is followed by an open-label crossover phase (Phase II: 5 daily sessions of active tDCS) for participants in the sham arm who did not respond, and an open-label maintenance phase (Phase III: active tDCS twice a week for up to 2 months) for responders from both arms (at least 2-point reduction on the pain VAS). Randomization is performed only once, at the start of the acute phase.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de investigación e innovación biomédica de Cádiz
- Sponsor type
- University, hospital or other
- Collaborators
- ESAME BIOMEDICAL S.L.
- Responsible party
- Sponsor
- Investigators
- Rocío Gómez-Molinero, PhD, Principal investigator, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912775
- Sponsor's protocol ID
- SICEIA-2026-002563
- Other IDs
- PID2024-157822OA-I00, ONCOSTIM-CT-01
- Acronym
- ONCOSTIM
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging the Therapeutic Benefits of Transcranial Direct Current Stimulation to Treat Chemotherapy-related Chronic Pain and Psycho-cognitive Comorbidities in Cancer Survivors
- ClinicalTrials.gov ID
- NCT07912775
- Acronym / sponsor ID
- ONCOSTIM / SICEIA-2026-002563
- Conditions
- Chronic Pain, Neuropathic Pain, Cancer Survivors, Anxiety, Depression, Cognitive Dysfunction
- Keywords
- Transcranial Direct Current Stimulation, tDCS, Noninvasive Brain Stimulation, Neuromodulation, Chemotherapy, Cancer Survivorship, Primary Motor Cortex, Salivary Cortisol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto de investigación e innovación biomédica de CádizUniversity, hospital or other
- Collaborators
- ESAME BIOMEDICAL S.L.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 3 Nov 2026 (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.
The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) combined with a working-memory task can treat chronic pain and related emotional and cognitive problems after chemotherapy in adult cancer survivors. tDCS is a non-invasive and painless technique that uses a very weak electrical current, applied through two small electrodes on the head, to modulate the activity of certain brain areas. The main questions it aims to answer are:
- Does tDCS reduce chronic pain intensity after chemotherapy in cancer survivors?
- Does tDCS also reduce anxiety, depression, and cognitive problems, and improve the regulation of cortisol, a stress-related hormone?
- Are the effects on pain, anxiety, depression, cognitive problems, and cortisol sustained when treatment continues with a maintenance phase of up to 2 months?
Researchers will compare real tDCS to sham (placebo) tDCS, a look-alike procedure that does not deliver effective stimulation, to see if real tDCS works to reduce pain and improve these symptoms.
Participants will:
- Receive real or sham tDCS (assigned by chance) in 5 daily sessions over 1 week. Each session lasts 20 minutes: 10 minutes at rest and 10 minutes while doing a working-memory task
- If they did not respond to sham tDCS, be offered 5 additional daily sessions of real tDCS
- If they respond to treatment, continue with real tDCS twice a week for up to 2 months
- Complete assessments of pain, mood, memory, attention, and quality of life before treatment, after each phase, and during and at the end of the maintenance phase
- Collect saliva samples to measure cortisol
Detailed description
Background and rationale. Chronic pain affects a large proportion of cancer survivors and is often accompanied by anxiety, depression, and cognitive impairment after chemotherapy. Current treatments rely heavily on opioids, which have significant side effects. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has shown analgesic effects in some cancer populations, but evidence in cancer survivors, beyond breast cancer, is scarce. This study evaluates tDCS combined with a working-memory task as an adjuvant treatment for chronic pain after chemotherapy and its associated psycho-cognitive comorbidities, both in the short term (acute phase) and over a maintenance period of up to 2 months.
Study design. This is a randomized, double-blind, sham-controlled, parallel-group clinical trial in the acute phase, followed by an open-label crossover phase for non-responders who received sham, and an open-label maintenance phase with active tDCS for responders. It is conducted at university hospitals in the province of Cádiz, Spain. Participants are randomly assigned to active or sham tDCS using a computer-generated randomization sequence kept by independent personnel. Neither participants nor the staff delivering the intervention know the assigned condition during the acute phase.
Procedures. Phase I (acute, double-blind): participants receive 5 consecutive daily sessions (one week) of active or sham tDCS. Stimulation is delivered with a battery-driven constant-current stimulator (Nurostym tES, CE-marked) through two saline-soaked sponge electrodes, with the anode over the primary motor cortex (C3/C4, 10-20 system, contralateral to the most affected side) and the cathode over the contralateral supraorbital region. Active stimulation consists of 2 mA for 20 minutes, with 30-second ramp-up and ramp-down. In sham stimulation, current is applied only briefly at the beginning and end of the session to mimic the sensation of active stimulation. During each 20-minute session, in both conditions, participants receive stimulation at rest for the first 10 minutes and perform the Sternberg working-memory task during the following 10 minutes. At the end of the acute phase, participants are asked which condition they believe they received, to check the integrity of blinding.
Phase II (open-label crossover): participants who received sham tDCS and did not respond receive 5 additional consecutive daily sessions of active tDCS.
Phase III (maintenance, open-label): participants who respond to treatment, defined as a reduction of at least 2 points in pain intensity on the visual analogue scale (VAS) relative to baseline at the end of the acute phase or the crossover phase, receive two sessions of active tDCS per week for up to 2 months as an add-on to standard care, following the same stimulation and task scheme.
Assessments. Assessments are performed at baseline (T0), after the acute phase (T1), after the crossover phase when applicable (T2), one month into the maintenance phase (T3), and at the end of the maintenance phase (T4). Pain intensity, anxiety, depression, cognitive function, quality of life, and diurnal salivary cortisol are assessed at baseline and reassessed after the acute and crossover phases and during and at the end of maintenance, to determine whether the effects of tDCS are sustained over time. Cortisol is collected at home on two consecutive days and analyzed by commercial immunoassay. Samples are coded, used only for research purposes, and processed in duplicate by the research unit. Safety is monitored continuously during each session and at the scheduled visits, with adverse events recorded in the case report form.
Statistical analysis. Sample size was calculated for an expected between-group difference of 2 points in pain intensity (95% confidence, 80% power), giving 25 participants per group, increased to 60 in total to account for attrition. The main analysis follows the intention-to-treat principle. Groups and time points are compared with ANOVA and MANOVA with post hoc corrections. Regression, mediation, moderation, and path analyses will explore the role of cortisol and of clinical variables, including sex, in the response to tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, parallel-group, sham-controlled acute phase (Phase I: 5 daily sessions over 1 week) with two arms: active tDCS and sham tDCS. It is followed by an open-label crossover phase (Phase II: 5 daily sessions of active tDCS) for participants in the sham arm who did not respond, and an open-label maintenance phase (Phase III: active tDCS twice a week for up to 2 months) for responders from both arms (at least 2-point reduction on the pain VAS). Randomization is performed only once, at the start of the acute phase.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCS with Sternberg taskPhase I (acute, double-blind): 5 consecutive daily sessions of active tDCS (2 mA, 20 minutes, 30-second ramp-up and ramp-down) combined with the Sternberg working-memory task (10 minutes at rest, then 10 minutes performing the task). Responders (at least 2-point reduction on the pain VAS from baseline) continue to Phase III (maintenance, open-label): active tDCS with the same scheme twice a week for up to 2 months. |
| Sham tDCS | Sham comparator | Device: Sham tDCS with Sternberg taskPhase I (acute, double-blind): 5 consecutive daily sessions of sham tDCS (brief ramp-up and ramp-down at the beginning and end of the session, without sustained stimulation) combined with the Sternberg working-memory task (10 minutes at rest, then 10 minutes performing the task). Non-responders then receive Phase II (open-label crossover): 5 consecutive daily sessions of active tDCS. Responders, after Phase I or Phase II, continue to Phase III (maintenance, open-label): active tDCS twice a week for up to 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of breast, prostate, lung, or colorectal cancer.
- Presence of chronic pain related to the cancer or its treatment, with a DN4 score ≥ 4
- Refractory to medical treatment for at least two months.
- Completion of systemic chemotherapy.
- Age ≥ 18 years.
Key exclusion criteria (4 listed)
- Relevant psychiatric or neurological disorders, such as dementia, psychosis, or epilepsy.
- Concomitant disabling medical conditions.
- Intracranial metallic implants or pacemakers.
- Extensive myocardial ischemia.
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 tDCS with Sternberg taskAlso: tDCS, Nurostym tESNurostym tES stimulator (Neuro Device Group SA, Poland; CE-marked) with two saline-soaked sponge electrodes. Anode over the primary motor cortex (C3/C4, 10-20 system, contralateral to the most affected side), cathode over the contralateral supraorbital region. 2 mA for 20 minutes with 30-second ramp-up and ramp-down. During each session, the first 10 minutes are at rest and the next 10 minutes are while performing the Sternberg working-memory task. Acute phase and crossover: 5 consecutive daily sessions. Maintenance: 2 sessions per week for up to 2 months. | Device | Active tDCS |
| Sham tDCS with Sternberg taskAlso: Sham stimulation, Sham tDCS, Nurostym tES (sham mode)Same device, electrode placement, and session schedule as active tDCS, with current delivered only during the 30-second ramp-up and ramp-down at the beginning and end of the session to mimic the sensation of active stimulation, without sustained stimulation. Participants also perform the Sternberg working-memory task (10 minutes at rest, then 10 minutes performing the task). 5 consecutive daily sessions in the acute phase. | Device | Sham tDCS |
Primary outcome
Change in pain intensity (Visual Analogue Scale, VAS) after the acute phase
Time frame: Baseline (T0) and after the acute phase at 1 week (T1)
Change from baseline in pain intensity measured with the Visual Analogue Scale (VAS), comparing active tDCS with sham tDCS. Scores range from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate a worse outcome. Responders are defined as participants with a reduction of at least 2 points from baseline.
10 secondary outcomes
Change in pain intensity (Visual Analogue Scale, VAS) from the end of the acute phase through maintenance
Time frame: From the end of the acute phase at 1 week (T1) to the end of maintenance at up to 2 months (T4)
Change in pain severity and interference (Brief Pain Inventory, BPI)
Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in anxiety and depression (Hospital Anxiety and Depression Scale, HADS)
Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in global cognitive function (Montreal Cognitive Assessment, Spanish version, MoCA-S)
Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in information processing speed (Symbol Digit Modalities Test, SDMT)
Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in sustained attention and working memory (Paced Auditory Serial Addition Test, PASAT-3)
Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in verbal fluency (Controlled Oral Word Association Test, COWAT)
Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in verbal learning and memory (Rey Auditory Verbal Learning Test, RAVLT)
Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in quality of life (World Health Organization Quality of Life - Brief Version, WHOQOL-BREF)
Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Change in diurnal salivary cortisol
Time frame: Baseline (T0), 1 week (T1), 2 weeks (T2), 1 month of maintenance (T3), and end of maintenance at up to 2 months (T4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Rocío Gómez-Molinero, PhD principal investigator
University of Cadiz
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 tDCS with Sternberg task in people with Chronic Pain and Neuropathic Pain, run by Instituto de investigación e innovación biomédica de Cádiz at 2 sites in Spain.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rocío Gómez-Molinero, PhD (+34956011240, rocio.gomez@uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (Visual Analogue Scale, VAS) after the acute phase (time frame: Baseline (T0) and after the acute phase at 1 week (T1)). 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 3 Nov 2026.