TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain (TDCS)

May 13, 2024 updated by: Clarice Tanaka, University of Sao Paulo General Hospital

Effects of Transcranial Stimulation by Direct Current Associated With Laterality Trainnning in Patients With Chronic Neck Pain

Chronic neck pain leads to decreased quality of life and absenteeism at work, generating great personal and socio-economic impact. It has been shown that patients with chronic pain have late recognition of the laterality of the hand, which is related to the duration of symptoms and pain evoked by the execution of the movement. These findings suggest that chronic pain and the consequent disuse of certain motor functions may involve a reorganization of the cortical representation of the body scheme or motor planning.

Non-invasive neuromodulation, such as transcranial direct current stimulation (TDCS), allows modulating cortical excitability and promoting pain relief.

This study intends to verify the effects of the association of noninvasive brain stimulation with TDCS with an intervention with visual and motor stimuli related to laterality in patients with neck pain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be controlled, randomized, double-blind and will include patients with chronic neck pain, divided into four groups:

  1. active TDCS associated with laterality recognition stimuli (n = 25);
  2. active TDCS associated with landscape recognition stimuli (n = 25);
  3. TDCS sham associated with laterality recognition stimuli (n = 25);
  4. TDCS sham associated with landscape recognition stimuli (n = 25);

Eight induction sessions will be held twice a week for four weeks. Patients who present a positive response in the first reassessment (responders) will remain in the study follow-up and will undergo a weekly maintenance session, for four weeks, and two more biweekly sessions.

The following instruments will be used for evaluation: motor safety thresholds through a MagVenture pulse generator with a flat surface coil, figure 8; OPAL, device with sensors; Recognize™ application; Visual Analog Scale (VAS); Brief Pain Inventory (BDI); Clinical Global Impression - ICG (patient and evaluated version); Pain McGill Standard Questionnaire - Short Format; Hospital Anxiety and Depression Scale (HAD); 36-item summary health survey from the Medical Outcomes Study (SF-36); Mini best test; neurodynamic tests (upper limb tension tests); and quantitative sensory tests. In addition to the pre- and post-intervention assessments, there will be post-treatment follow-up performed three, six and 12 months after randomization by telephone or e-mail. It is expected that the combined application of tDCS with stimuli related to laterality will have positive effects in patients with neck pain, impacting on variables such as pain, functional movements and quality of life of these patients.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Recruiting
        • Universidade de Sao Paulo
        • Contact:
          • Clarice Tanaka, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • participants over 18 years old;
  • pain in the cervical region, lasting more than three months and with intensity greater than 40/100 on the visual analog scale

Exclusion Criteria:

  • history of seizures or epilepsy,
  • history of head trauma,
  • intracranial hypertension,
  • intracranial metal clip,
  • pregnant or breastfeeding women,
  • skin lesions at the current application site;
  • changes in sensitivity and allergy in the electrode positioning region.
  • intermittent pain;
  • Cancer;
  • cardiac pacemaker;
  • severe spinal diseases, such as recent fractures or ankylosing spondylitis;
  • serious cardiorespiratory diseases;
  • participants who refuse to sign the Free and Informed Consent Form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active bipolar TDCS associated with laterality recognition stimuli
Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Individuals with active bipolar TDCS will receive a 2mA stimulus for twenty minutes. Meanwhile, they will use the Regognise hand application to discriminate right/left side of hand images.
Device: TDCS
Technique of non-invasive brain stimulation by direct current (TDCS) which involves the modulation of excitability and brain activity, capable of promoting reorganization of the cortical representation of the body schema or motor planning, and consequently, pain relief.
Device: Recognize (hand) - Laterality
This technique stimulates the ability to recognize hand images as right/left quicklPatients with chronic pain present delayed recognition of hand laterality, which is related to the duration of symptoms and the pain evoked by the execution of the movement. Thus, this technique can have beneficial effects in breaking the pain.
Active Comparator: Active bipolar TDCS associated with landscape recognition stimuli

Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Individuals with active bipolar TDCS will receive a 2mA stimulus for twenty minutes.

At the same time, they will be guided to recognize landscapes that do not refer to the recognition of laterality.
Device: TDCS
Technique of non-invasive brain stimulation by direct current (TDCS) which involves the modulation of excitability and brain activity, capable of promoting reorganization of the cortical representation of the body schema or motor planning, and consequently, pain relief.
Other: Landscape recognition
Image recognition training that does not refer to right/left discrimination.
Active Comparator: Sham TDCS associated with laterality recognition stimuli
Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Stimulation will remain inactive for the 20 minutes. Meanwhile, they will use the Regognise hand app to discriminate right/left hand images.
Device: Recognize (hand) - Laterality
This technique stimulates the ability to recognize hand images as right/left quicklPatients with chronic pain present delayed recognition of hand laterality, which is related to the duration of symptoms and the pain evoked by the execution of the movement. Thus, this technique can have beneficial effects in breaking the pain.
Other: Sham TDCS
TDCS sham: The device remains inactive for 20 minutes.
Placebo Comparator: Sham TDCS associated with landscape recognition stimuli
Participants will have carbon electrodes positioned, with contact through a 5x7cm sponge moistened in saline solution, with the anode on M1 and the cathode in the supra-orbital region. Stimulation will remain inactive for the 20 minutes. At the same time, they will be guided to recognize landscapes that do not refer to the recognition of laterality.
Other: Landscape recognition
Image recognition training that does not refer to right/left discrimination.
Other: Sham TDCS
TDCS sham: The device remains inactive for 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain symptoms
Time Frame: up to 3 months
Change from Baseline in pain symptoms on the Visual Scale after treatment
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression
Time Frame: up to 3 months
Change from Baseline in pain severity on the Clinical Global Impression scale after treatment
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2023

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94350518.6.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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