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

Spinal Cord Injury Clinical Trial

Official title:

Investigation of the Mechanisms of Transcranial Direct Current Stimulation of Motor Cortex for the Treatment of Chronic Pain in Spinal Cord Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01112774
• Other study ID #: 2010p000190
• Status: Terminated
• Phase: N/A
• Start date: April 2010
• Est. completion date: August 14, 2013

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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

More study details will be provided by Spaulding Rehabilitation Hospital.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 14, 2013
• Est. primary completion date: August 14, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• Transcranial direct current stimulation
Stimulation will be applied at 2 mA for a total of 20 minutes.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurophysiological activity changes after treatment with tDCS	Magnetic resonance spectroscopy (MRS), electroencephalogram (EEG), transcranial magnetic stimulation (TMS)	baseline, 2 weeks treatment and follow up (2 weeks)
Secondary	Pain changes	(i) Demographic Data; (ii) Visual analog scale (VAS) for pain; (iii) Analgesic use; (iv) Quality of Life Scale (QOLS); (v) Patient Global Assessment (PGA); (vi) Clinical Global Impression (CGI); (vii) Beck Depression Inventory (BDI); (viii) Visual Analog Scale (VAS) for anxiety; (ix) tDCS Side Effects Questionnaire; (x) Mini-mental status exam; and (xi) Validation of Blinding	Baseline, 2 weeks treatment and follow up (2 weeks)