Application of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Pain After Spinal Cord Injury

Mass General Brigham

Status: Terminated

Conditions: Spinal Cord Injury

Treatments: Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01112774

2010p000190

Details and patient eligibility

About

The purpose of this study is to determine whether the novel treatment of transcranial direct current stimulation (tDCS) could decrease the pain perception of those with spinal cord injury.

We will also determine whether these changes are correlated with the clinical outcome (pain reduction).

Full description

The active tDCS stimulation sessions will be compared to sham stimulation.

More study details will be provided by Spaulding Rehabilitation Hospital.

Enrollment: 24 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

STUDY ELIGIBILITY CRITERIA (similar to the criteria of the Interstitial Cystitis Network)

1. Providing informed consent to participate in the study

2. 18 to 64 years old

3. with traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)

4. stable chronic pain for at least the three preceding months(for spinal cord injury only)

5. score higher or equal to 4cm (0 cm= 'no pain' and 10cm='worst possible pain') on the Visual Analogue Scale (VAS) for pain perception at the baseline/start of the treatment(for spinal cord injury only)

6. refractoriness to drugs for pain relieve - such as tricyclic antidepressants, antiepileptic drugs and/or narcotics (pain resistant to at least 2 of these drugs supplied in adequate dosages for six months) (for spinal cord injury only)

7. pain is not attributable to other causes, such as peripheral inflammation.

8. No clinically significant or unstable medical or psychiatric disorder

9. No history of substance abuse

10. No neuropsychiatric comorbidity

11. No implanted devices for pain control, such as vagal or deep brain stimulators

12. No contraindications to tDCS:

    • metal in the head
    • implanted brain medical devices

13. No pregnancy

14. Eligible to MRI according to MRI screening checklist.

15. No use of ventilators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

tDCS/Spinal cord injury

Experimental group

Description:

Subjects will be randomized to receive 10 sessions of either active or sham tDCS. Stimulation will be given on consecutive days (Monday- Friday) at 2 mA over the primary motor cortex area.

Treatment:

Device: Transcranial direct current stimulation

tDCS/Healthy subjects

Experimental group

Description:

Subjects will receive 2 sessions of stimulation: one active and one sham tDCS on two separate visits. The order in which they receive the stimulation will be randomized. Stimulation parameters will be at 2 mA for a total of 20 minutes.

Treatment:

Device: Transcranial direct current stimulation