TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain

NCT06204627 | Recruiting

• 1 other identifier: 94350518.6.0000.0068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neck Pain; Chronic Pain

Keywords

chronic pain; neck pain; functional laterality; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Pain symptoms

  Change from Baseline in pain symptoms on the Visual Scale after treatment

  up to 3 months

Secondary Outcomes (1)

• Clinical Global Impression

  up to 3 months

Study Arms (4)

Active bipolar TDCS associated with laterality recognition stimuli

ACTIVE COMPARATOR

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; Device: Recognize (hand) - Laterality

Active bipolar TDCS associated with landscape recognition stimuli

ACTIVE COMPARATOR

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; Other: Landscape recognition

Sham TDCS associated with laterality recognition stimuli

ACTIVE COMPARATOR

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; Other: Sham TDCS

Sham TDCS associated with landscape recognition stimuli

PLACEBO COMPARATOR

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: Sham TDCS; Other: Landscape recognition

Interventions

TDCS DEVICE

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.

Active bipolar TDCS associated with landscape recognition stimuli; Active bipolar TDCS associated with laterality recognition stimuli

Recognize (hand) - Laterality DEVICE

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 bipolar TDCS associated with laterality recognition stimuli; Sham TDCS associated with laterality recognition stimuli

Sham TDCS OTHER

TDCS sham: The device remains inactive for 20 minutes.

Sham TDCS associated with landscape recognition stimuli; Sham TDCS associated with laterality recognition stimuli

Landscape recognition OTHER

Image recognition training that does not refer to right/left discrimination.

Active bipolar TDCS associated with landscape recognition stimuli; Sham TDCS associated with landscape recognition stimuli

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Universidade de São Paulo

São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Clarice Tanaka

CONTACT

551126616867; cltanaka@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be controlled, randomized and double-blind.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: January 12, 2024
• Study Start: September 30, 2023
• Primary Completion: August 30, 2024
• Study Completion: December 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)