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, Israel, Portugal, Romania, Spain and Switzerland.

This project focuses on the approach to oncologic pain and 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 personalize 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.

The 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.

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

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

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

ONCODEP

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, individualized and home-based treatment to improve the mood and cognitive functioning (attention, memory, mental agility…) of women with breast cancer.

The objectives of the study are:

To analyze the efficacy and feasibility of the intervention to treat depressive symptomatology (low mood, loss of interest, pessimism…) associated with breast cancer.
To analyze the efficacy and feasibility of the intervention on the complaints and cognitive functioning (problems in maintaining attention, forgetfulness, “chemofog”…) of the participants.
To evaluate the efficacy of the treatment in the medium and long term.
To identify potential biomarkers in saliva associated with the efficacy of the intervention.
To characterize the patients for whom the intervention is most effective.

Participation consists of

Assessment sessions

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

Treatment

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

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

Proyecto Home-tES

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 individualized 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 personalizing the treatment. The evaluation protocol will include:
- A comprehensive assessment of participants’ physical and psychological status, as well as their life style.
- A standardized 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 will evaluate the clinical status of the participants with validated questionnaires and we will assess the central mechanisms of pain modulation. In addition, we will compare the results of this evaluation with a group of participants without chronic pain.
In the second phase, we will determine the efficacy of home-tES treatments for the relief of pain and associated symptoms.
In the third phase, we will analyze the usefulness of patient profiles to predict the efficacy of a home-tES treatments (tDCS and tACS) in chronic pain patients.

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

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