Effects of Transcranial Direct Current Stimulation (tDCS) on Patients With Chronic Orofacial Pain

NCT01883245 | Terminated Phase 2 DMC

• 1 other identifier: Orofacial pain_tDCS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients affected by chronic orofacial pain represent an emergent medical problem due to the lack of knowledge on the cause, pathophysiology and psychology of many of these conditions, that belongs to a multifactorial origin. Particularly, temporomandibular joint disorders involve a series of symptoms that refers both to intrinsic and extrinsic joint conditions where pain can be associated to a reduction of the joint movement, click or to other sounds of the joint. The lack of a recognized causal therapy led to the suggestion of many treatment modalities with a multidisciplinary approach for the management of symptoms that include the use of occlusal splints, physiotherapy-speech therapy, behavioral and physical therapy, drugs, chirurgical approaches. In most cases these strategies together allow the control of the symptoms, even though they aren't completely resolutive. In these patients is frequent chronic pain and ineffectiveness of common drugs used. It has been demonstrated how transcranial electrical brain stimulation with direct current (tDCS) is able to reduce the intensity and the duration of chronic pain. Stimulating the motor cortex can reduce pain by modulating brain activities in the areas involved in cerebral circuits controlling pain, such as thalamus, facilitating the descendant inhibitory mechanisms and enhancing the number of opiates receptors. This clinical trial is based on the evaluation of the effects of tDCS on pain and on activities daily living (ADL) participation patients with chronic orofacial pain that don't respond to other treatments.

Conditions

Orofacial Pain

Keywords

Orofacial chronic pain; tDCS; Transcranial direct current stimulation; Brain stimulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Visual Analogue Scale (VAS) for pain

  Visual analogue scale measure for pain. Score range from 0-10. For rating overall pain: mild = 1-3, moderate = 4-7, severe = 8-10 For rating Chronic Pain, excellent internal consistency for a single pair of rating between Numeric Pain Rating Scale and Visual Analogue Scale (r = 0.86)

  1) one day pre-tDCS 5 days treatment. 2) Every day, for 5 days pre and post tDCS stimulation. 3) one day post tDCS 5 days treatment. 4)Follow up at one month.

Secondary Outcomes (6)

• Research Diagnostic Criteria Temporomandibular disorders (RDC/TMD) AXIS I

  1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up

• Research Diagnostic Criteria Temporomandibular disorders RDC/TMD AXIS II

  1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up

• Symptoms Checklist 90-R scales (SCL 90-R)

  1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up

• Electrical and pressure pain threshold

  1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up

• Oral Health Impact Profile 49 (OHIP 49)

  1) one day pre 5 days tDCS treatment. 2) one day post 5 days tDCS treatment 3) One month follow up

Study Arms (2)

sham tDCS

ACTIVE COMPARATOR

This group will receive sham-tDCS for 5 days. The anode will be placed on the primary motor cortex (M1) of the dominant hemisphere and the cathode on the contralateral supraorbital area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries. This continuous stimulation lasted 30 seconds, with an intensity of 1 milliampere.

Device: sham tDCS

real tDCS

EXPERIMENTAL

This group will receive continuous stimulation lasting 20 minutes daily, for 5 days. Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the dominant hemisphere and the cathode on the contralateral supraorbital area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries. This continuous stimulation lasted 20 minutes, with an intensity of 1 milliampere.

Device: real tDCS

Interventions

real tDCS DEVICE

2 milliampere real direct current stimulation for 20 minutes daily for 5 days.

real tDCS

sham tDCS DEVICE

2 milliampere sham direct current stimulation for 20 minutes daily for 5 days.

sham tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female between 18 and 75 years old
• Clinic history of previous orofacial and/or dental surgery
• Chronic orofacial pain for more than a year measurable by the VAS more than 3 .
• Pain not responsive to pharmacological treatment (analgesic, anti inflammatory, opiates, antidepressant drugs and physiotherapy modalities)

You may not qualify if:

• Contraindication to tDCS: presence of metallic implants that can be stimulated, moved or overheated by electric current, positive anamnesis for epilepsy, implantable systems ( ventriculoperitoneal shunt, pacemaker, intracranial pumps, intracranial metallic systems)
• Major neurological or psychiatric pathologies
• Pregnancy
• Severe hepatorenal and cardiopulmonary diseases

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, Ferrara, 44124, Italy

Location

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 21, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 19, 2014

Record last verified: 2014-01

Locations

IT (1)