Back to resultsApplication of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Pain After Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Transcranial direct current stimulation, Spinal cord injury, Chronic pain, Brain excitability
Eligibility Criteria
STUDY ELIGIBILITY CRITERIA (similar to the criteria of the Interstitial Cystitis Network)
- Providing informed consent to participate in the study
- 18 to 64 years old
- with traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)
- stable chronic pain for at least the three preceding months(for spinal cord injury only)
- 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)
- 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)
- pain is not attributable to other causes, such as peripheral inflammation.
- No clinically significant or unstable medical or psychiatric disorder
- No history of substance abuse
- No neuropsychiatric comorbidity
- No implanted devices for pain control, such as vagal or deep brain stimulators
No contraindications to tDCS:
- metal in the head
- implanted brain medical devices
- No pregnancy
- Eligible to MRI according to MRI screening checklist.
- No use of ventilators
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
tDCS/Spinal cord injury
tDCS/Healthy subjects
Arm 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.
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.
Outcomes
Primary Outcome Measures
Neurophysiological activity changes after treatment with tDCS
Magnetic resonance spectroscopy (MRS), electroencephalogram (EEG), transcranial magnetic stimulation (TMS)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01112774
First Posted
April 20, 2010
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01112774
Brief Title
Application of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Pain After Spinal Cord Injury
Official Title
Investigation of the Mechanisms of Transcranial Direct Current Stimulation of Motor Cortex for the Treatment of Chronic Pain in Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding ended
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 14, 2013 (Actual)
Study Completion Date
August 14, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed Description
The active tDCS stimulation sessions will be compared to sham stimulation.
More study details will be provided by Spaulding Rehabilitation Hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Transcranial direct current stimulation, Spinal cord injury, Chronic pain, Brain excitability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS/Spinal cord injury
Arm Type
Experimental
Arm 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.
Arm Title
tDCS/Healthy subjects
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
electrical stimulation, tDCS
Intervention Description
Stimulation will be applied at 2 mA for a total of 20 minutes.
Primary Outcome Measure Information:
Title
Neurophysiological activity changes after treatment with tDCS
Description
Magnetic resonance spectroscopy (MRS), electroencephalogram (EEG), transcranial magnetic stimulation (TMS)
Time Frame
baseline, 2 weeks treatment and follow up (2 weeks)
Secondary Outcome Measure Information:
Title
Pain changes
Description
(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
Time Frame
Baseline, 2 weeks treatment and follow up (2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
STUDY ELIGIBILITY CRITERIA (similar to the criteria of the Interstitial Cystitis Network)
Providing informed consent to participate in the study
18 to 64 years old
with traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)
stable chronic pain for at least the three preceding months(for spinal cord injury only)
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)
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)
pain is not attributable to other causes, such as peripheral inflammation.
No clinically significant or unstable medical or psychiatric disorder
No history of substance abuse
No neuropsychiatric comorbidity
No implanted devices for pain control, such as vagal or deep brain stimulators
No contraindications to tDCS:
metal in the head
implanted brain medical devices
No pregnancy
Eligible to MRI according to MRI screening checklist.
No use of ventilators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Application of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Pain After Spinal Cord Injury
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