Active BAP projects - BAP Brainandpain

Active projects

PAINLESS project

PAINLESS is a European multicenter project led by María Teresa Carrillo-de-la-Peña, with the participation of 10 countries: Belgium, Czech Republic, Denmark, France, Germany, Portugal, Romania, Spain, Switzerland and Israel.

This project focuses on a novel approach to managing oncologic pain and its associated symptoms.

To this end, we intend to:

Develop a specific assessment protocol for patients with cancer pain and create an online platform to improve the diagnosis and monitoring of these patients.
Identify biomarkers of the central mechanisms of pain modulation with quantitative sensory evaluation procedures and EEG, which allow us to predict the onset of cancer pain and personalise treatment.
Assess the feasibility, safety, effectiveness, and cost-effectiveness of treatment with transcranial electrical stimulation (tES) applied at home to relieve pain and other symptoms in cancer patients.

PAINLESS is funded by the European Union (Project ID: 101057367). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA), for which they cannot be held responsible.

PAINLESS project is composed of three studies:

Study 1: A longitudinal study of 450 recently diagnosed cancer patients to assess the power of selected biomarkers and clinical symptoms to predict the occurrence of chronic cancer pain.
Study 2: Cross-sectional study with 750 cancer patients, 500 with pain and 250 without pain, to determine possible factors associated with cancer pain.
Study 3: Randomised clinical trial with a control group where we will evaluate the efficacy of neuromodulation techniques (tDCS and tACS) applied at home in the treatment of patients with cancer pain.

PAINLESS is a Horizon Europe initiative: HORIZON-HLTH-2021-DISEASE-04 (2022-2027); Project ID 101057367.

For more information on the PAINLESS project, please visit the official PAINLESS.eu website.

The three PAINLESS studies will improve our understanding of the mechanisms of oncologic pain. They will also allow us to assess the efficacy of a neuromodulation treatment for pain relief in palliative care programmes across Europe.

KNOwMorePain project

Fibromyalgia is a multidimensional condition characterised by chronic widespread pain and a heterogeneity of associated symptoms, with no effective health response to patients’ suffering. Its exact causes are unknown, nor are there objective tests for its diagnosis. Further, fibriomyalgia treatment is symptomatic, mainly based on pharmacological therapies, with limited efficacy. Multicomponent therapies appear to be effective in the short and medium term, but many fail to maintain their effects in the long term.

All the abovementioned aspects imply a high health and social burden, but most importantly, a severe impact on patients’ quality of life. kNOwMorePain aims to:

better understand the mechanisms of neural plasticity and central modulation of pain underlying this disease;
identify sensitive and valid diagnostic biomarkers to facilitate diagnosis and guide personalised treatment; and
to test a multicomponent treatment programme combining education in pain neuroscience, exercise and neuromodulation (central – with transcranial electrical stimulation – and peripheral – with percutaneous cervical and lumbar stimulation).

This therapeutic option, which has not been explored before, seeks to increase the long-term efficacy of available interventions through the synergistic action of these techniques to modify the dysfunctional plasticity mechanisms responsible for chronic pain.

KNOwMorePain Improving knowledge of pain mechanisms and treatment in Fibromyalgia using an integrative strategy.

ONCODEP project

ONCODEP study (NCT06053775) is a project led by Maria-Teresa-Carrillo-De-La-Peña (University of Santiago de Compostela) in collaboration with Carlos Spuch Calvar (Fundación Biomédica Galicia Sur) and different Oncology units of the Galician Health Service (SERGAS).

ONCODEP offers an evidence-based, individualised and home-based treatment to improve mood state and cognitive functioning (attention, memory, mental agility…) of women with breast cancer. The intervention includes a combination of computerised cognitive training and non-invasive neuromodulation application that patients will be able to complete at their homes.

The objectives of the study are:

To analyse the efficacy and feasibility of the intervention to treat depressive symptomatology (low mood, loss of interest, pessimism, etc.) and to improve cognitive performance and alleviate complaints about cognitive functioning (problems in maintaining attention, forgetfulness, “chemofog”, etc.) in breast cancer patients.
To evaluate the efficacy of the treatment in the medium and long term.
To characterise the patients for whom the intervention is most effective by identifying potential biomarkers in saliva associated with the intervention effectiveness.

Participation consists of

Assessment sessions

Three face-to-face visits (before and after treatment, and one month after treatment end) to collect clinical and neuropsychological data and saliva samples (Faculty of Psychology or Oncology Unit of reference).
Two online follow-up tests at 3 and 6 months after treatment end to collect neuropsychological data.

Treatment

Online cognitive training combined or not with neuromodulation (transcranial direct current stimulation – tDCS- or alternating current stimulation -tACS-).
Fifteen daily sessions of 20 minutes (participant’s home).

ONCODEP collaborates with oncology professionals to improve the mood state and mental functioning of women with breast cancer. We offer a safe, individualised and evidence-based treatment at home.

ONCOQUEST project

ONCOQUEST aims to construct and validate questionnaires directed to the oncological population to examine essential aspects of their medical process and quality of life. Specifically, we are developing questionnaires to assess cognitive complaints (ONCOFOG -OFQ questionnaire) and coping with pain (COPPAIN questionnaire). In addition, a questionnaire on self-efficacy in coping with cancer (Cancer Behaviour Inventory Brief -CBI-B-) will be translated into Spanish and validated.

How?

Pilot study: 25 patients from the Oncology Units of Santiago de Compostela, Vigo and Ourense will be asked about their impressions of the tests and suggestions for improvement to elaborate the final version of the questionnaires.

Validation study: the final versions of the questionnaires will be disseminated through patients’ associations, BaP social networks, etc. In this way, the responses of 200 participants will be collected to study the reliability and validity of the developed tests.

This work will provide professionals working with cancer patients with short instruments to explore variables that affect the oncological process and quality of life of cancer patients and survivors.

These instruments could be helpful as a tool for detecting those patients who might need specific psychosocial intervention.

Brain and Pain Home-tES project

The Home-tES project is funded by the Spanish government and is headed by María Teresa Carrillo-de-la-Peña. It aims to alleviate pain and associated symptoms in patients with chronic pain by proposing an individualised home treatment model.

To this end, the project will focus on achieving the following sub-objectives:

Identify biomarkers of the central mechanisms of pain modulation that will allow personalising the treatment. The evaluation protocol will include:
- A comprehensive assessment of participants’ physical and psychological status, as well as their lifestyle.
- A standardised protocol to assess central pain modulation using quantitative sensory testing (QST) and electroencephalography (EEG).

To evaluate the feasibility, safety, effectiveness, and cost-effectiveness of home-applied transcranial electrical stimulation (tES) treatments: transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS).

The Home-tES project is divided into three phases:

In the first phase, we evaluate the clinical status of the participants with validated questionnaires and assess the central mechanisms of pain modulation.
In addition, we compare the results of this evaluation with a control group of participants without chronic pain.
In the second phase, we determine the efficacy of home-tES treatments for relieving pain and associated symptoms.
In the third phase, we analyse the usefulness of patient profiles to predict the effectiveness of the home-based tES treatments (tDCS and tACS) in chronic pain patients.

We are developing a protocol for tDCS and tACS stimulation at home for patients with chronic pain, performing a clinical study with placebo control (40% active tDCS stimulation on M1 – 40% active tACS stimulation on F3 – 20% sham tDCS/tACS stimulation), and analysing the effectiveness and cost-effectiveness of this intervention.

In the Home-tES project, we propose an individualised home-based treatment model for chronic pain management.