Home-based Transcranial Stimulation in the Treatment of Patients With Refractory Chronic Pain
Unknown statusNot applicableNCT05099406
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Refractory chronic pain represents a serious and limiting health condition which does not respond to standard pharmacological therapy. Thus, it emerges the necessity of new techniques to treat these group of diseases, such as the transcranial electrical stimulation (tES). This procedure induces a low-intensity electrical current through the scalp to modify the excitability of brain cells, thus facilitating changes in neural networks which may be dysfunctional in some chronic pain patients. The main objective of this research is to test the efficacy of two tES techniques, differentiated by applying direct or alternant electrical current, to reduce the pain intensity and to increase pain thresholds of these patients. Besides, intervention is implemented at home for patients themselves thanks to a portable and convenient stimulator device, after one training session provided by technicians. Researches can supervise the compliance of the treatment remotely, as the stimulator has a permanent connection with their computers. A home-based approach means a more comfortable and accessible treatment alternative for patients, since they do not have to attend to clinics everyday to receive the stimulation; the advantages become even more relevant in the pandemic context, since the risk of being infected is radically minimized. Despite the main purpose is to test the efficacy of tES to improve the pain suffered by patients, many other areas are considered as secondary end points for being intrinsically linked or affected by the disease, such as the interference in daily tasks provoked by pain, mood disorders (depression/anxiety), fatigue, life quality, physical functioning and sleep quality; these last two variables are measured with actigraph wristwatches, apart from specific questionnaires. Lastly, endogenous modulatory pain mechanisms are examined through sensory tests, namely Conditioned Pain Modulation and Temporal Summation of pain.
Study details
- Official title
- Brain and Pain (BaP): Understanding the Central Mechanisms of Pain to Improve Management of Patients With Refractory Chronic Pain
- Conditions
- Interventions
- Device: Transcranial electrical stimulation
- Sponsor
- University of Santiago de Compostela
- Collaborators
- Ministry of Science and Innovation, Spain; Health Research Institute of Santiago de Compostela - IDIS (Recruitment support); Fundación Biomédica Galicia Sur (Recruitment support)
- Start date
- 2022-01-01
- Primary completion
- 2023-05-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Suffering a chronic pain condition of non-cancer nature. Those patients who report chronic pain even after overcoming an oncological process are suitable to participate, but only if they have received the definitive medical discharge and have been free from radiotherapy/chemotherapy for at least twelve months. * Adult subjects (18-65 years old). * Subjects able to provide informed consent to participate in the study and to self-report pain. * Existing chronic pain which reaches an intensity of at least 4 on a 0-10 Numeric Rating Scale (NRS) on average over the past 3 months prior to enrolment. * Pain intensity of at least 5 on a 0-10 NRS over the week prior to enrolment. * Diagnosis of pharmaco-resistance to analgesic drugs across the WHO ladder. * Pharmacological regimen have kept stable for at least two months previous to the enrolment, and it must not suffer modifications during the whole research period. Exclusion Criteria: * Chronic pain derived from current cancer disease. * Pregnant women or women in fertile age not having efficacious contraception during the whole period of the study. * History of alcohol or drug abuse within the past 6 months as self-reported. * Suffering from unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease). * Intracranial ferromagnetic devices or implanted stimulator (basal ganglia stimulator, vagus nerve stimulation). * Antecedents of, or active epilepsy. * History of neurosurgery, psychiatric diseases other than anxiety or depression, traumatic brain injury with loss of consciousness, and/or cortical lesions.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05099406