Home-based Transcranial Stimulation in the Treatment of Patients With Refractory Chronic Pain

NCT05099406 | Unknown FDA Device

• 2 other identifiers: 2019-PN1332021-000804-39
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Keywords

Transcranial electrical stimulation; Fibromyalgia; Arthritis; Arthrosis; Low back pain; Migraine headaches; Anxiety disorders; Depression; Chronic fatigue; Sleep disorders; Pain assessment; EEG

Outcome Measures

Primary Outcomes (1)

• Self-reported pain intensity

  Participants must evaluate the intensity of their pain using an online version of a Numerical Rating Scale of eleven points (0-10), so that the higher the score is, the worse the pain is.

  Pre-treatment measure is the average of pain intensity of fifteen days previous to treatment; whereas the post-treatment measure is the average of fifteen days after treatment have finished

Secondary Outcomes (14)

• Global severity of chronic pain syndrome

  Participants will complete MPI one or two days before the treatment onset, and one or two days after treatment ending.

• Pressure pain threshold

  Pressure pain thresholds will be assessed in face-to-face laboratory sessions, which would take place one or two days before the treatment onset and one or two days after treatment ending.

• Heat pain threshold

  Heat pain thresholds will be assessed in face-to-face laboratory sessions, which would take place one or two days before the treatment onset and one or two days after treatment ending.

• Interference in daily living caused by pain

  Pain interference will be assessed in face-to-face laboratory sessions, which would take place one or two days before the treatment onset and one or two days after treatment ending.

• Life quality

  Life quality will be assessed one or two days before the treatment onset and one or two days after treatment ending.

Other Outcomes (3)

• Endogenous pain inhibition response

  CPM procedure will be performed at two time-points, this is, one or two days before and after treatment, in order to assess if tES treatment is capable of restoring any dysfunction in this inhibitory pain network.

• Endogenous pain facilitation response

  TSSP procedure will be performed at two time-points, this is, one or two days before and after treatment, in order to assess if tES treatment is capable of restoring any dysfunction in this facilitatory pain network.

• Electrical brain activity over diverse conditions

  EEG will be registered at two time-points, this is, one or two days before and one or two days after treatment.

Study Arms (3)

Transcranial direct current stimulation (tDCS)

ACTIVE COMPARATOR

Fifteen stimulation sessions applied with a daily frequency during an uninterrupted period of time which comprises just over two weeks. Current intensity of 2mA is applied during 20 minutes at the left M1, with anodal electrode placed in C3 and cathodal in FP2, following the International 10-20 EEG System. Ramp-up and ramp-down comprises 15 seconds at the beginning and end of the stimulation period.

Device: Transcranial electrical stimulation

Transcranial alternant current stimulation (tACS)

ACTIVE COMPARATOR

Fifteen stimulation sessions applied with a daily frequency during an uninterrupted period of time which comprises just over two weeks. Two electrodes will be placed at F3 and F4 and connected together for 10-Hz tACS (or the frequency which shows best sensitivity or specificity), and one electrode at Pz will be the return electrode. This setting is used to stimulate the somatosensory cortical region. Stimulation will last for 20 minutes, with a ramp-up and ramp-down of 15 seconds at the beginning and end of the session.

Device: Transcranial electrical stimulation

Sham stimulation

PLACEBO COMPARATOR

The electrode montage will be either the tDCS (for half of the participants) or the tACS montage (for the other half), and we will just apply the current at the ramps terms, but no current in the interval between the ramps which practically comprises the whole session. As for the two other group, fifteen sham stimulation sessions will be daily scheduled in a non-interrupted period of two weeks.

Device: Transcranial electrical stimulation

Interventions

Transcranial electrical stimulation DEVICE

By applying a low current over the cortex through the scalp, this technique can excite or inhibit the neural activity, thus modulating brain processes like pain perception and inducing relatively sustained changes in cortical excitability and neuroplasticity. Home-based transcranial electrical stimulation device consists of a custom headgear with fixed electrode sites and built-in cabling made for a simplistic setup for tDCS/tACS stimulation. Systems are equipped with strict dose control feature that provide reliable control over the intensity and timing of stimulation, turning these devices into a feasible and safe clinical alternative. The equipment is specifically designed for easy and simplistic self-setup and allows the researchers to remotely check the position of electrodes and also monitor the stimulation session.

Also known as: Transcranial direct current stimulation, Transcranial alternant current stimulation

Sham stimulation; Transcranial alternant current stimulation (tACS); Transcranial direct current stimulation (tDCS)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Ministry of Science and Innovation, Spain: collaborator
• Health Research Institute of Santiago de Compostela - IDIS (Recruitment support): collaborator
• Fundación Biomédica Galicia Sur (Recruitment support): collaborator

Study Sites (1)

University of Santiago de Compostela

Santiago de Compostela, A Coruña, 15701, Spain

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Chronic Pain; Fibromyalgia; Arthritis; Osteoarthritis; Low Back Pain; Migraine Disorders; Anxiety Disorders; Depression; Sleep Wake Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Joint Diseases; Back Pain; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• María Teresa Carrillo de la Peña

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Teresa Carrillo de la Peña, PhD

CONTACT

+34 625 76 32 25; mteresa.carrillo@usc.es

J. Antonio Vázquez Millán

CONTACT

joseantonio.vazquez.millan@rai.usc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Portable devices for applying the transcranial electrical stimulation are equipped with a software which allows a double-blinded procedure. The same computer program is in charge of randomly allocating patients to one of the three treatment groups. Thus, nor the researchers neither the participants will know what kind of stimulation is receiving each of them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular university professor (PhD)

Model Details: Participants will be randomly assigned to one of three treatment groups (40% active tDCS; 40% Active tACS; 20% Sham). Patients receiving sham stimulation will act as the control group.

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: October 29, 2021
• Study Start: January 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)