Effects of Transcranial Direct Current Stimulation (tDCS) and Visual Illusion on Chronic Pain Due to Spinal Cord Injury

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

The purpose of this study is to investigate the effects of Transcranial Direct Current Stimulation (tDCS) combined with watching a visual illusion on chronic pain due to spinal cord injury. The investigators hypothesize that active tDCS will reduce pain in subjects with spinal cord injury when compared to sham stimulation. The investigators will also measure changes in EEG data (alpha and beta frequencies) as well as motor cortex excitability.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain; Spinal Cord Injury
• Intervention / Treatment: Procedure: Transcranial Direct Current Stimulation (tDCS)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Spaulding Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

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 relief - 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

Exclusion Criteria:

1. Clinically significant or unstable medical or psychiatric disorder
2. History of substance abuse
3. Neuropsychiatric comorbidities, including: Documented traumatic brain injury (TBI), defined as damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia (PTA), or skull fracture, or objective neurological findings that can be reasonably attributed to TBI as assessed by the study PI
4. Implanted devices for pain control, such as vagal or deep brain stimulators

5. Contraindications to tDCS:

   • metal in the head
   • implanted brain medical devices
6. Pregnancy
7. Use of ventilators or ventilation support
8. Complete tetraplegic lesion (no motor function in the arms) (C3 to C8) as we will be measuring the motor evoked potential in the FDI (upper limbs); only tetraplegic patients with incomplete functional status and also as defined by the ability to elicit MEP in the FDI will be able to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active tDCS + visual illusion; Subjects will receive active tDCS while watching a visual illusion movie (legs walking on a treadmill). Stimulation will last for 20 minutes.	Procedure: Transcranial Direct Current Stimulation (tDCS); Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA. For active tDCS, the subject will undergo stimulation for 20 minutes. For sham stimulation, the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.; Other Names: low intensity 1x1 direct current stimulator
SHAM_COMPARATOR: Sham tDCS + visual illusion; Subjects will receive sham tDCS stimulation (30 seconds ramp up/ramp down) while watching a visual illusion movie (legs walking on a treadmill)	Procedure: Transcranial Direct Current Stimulation (tDCS); Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA. For active tDCS, the subject will undergo stimulation for 20 minutes. For sham stimulation, the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.; Other Names: low intensity 1x1 direct current stimulator
OTHER: Healthy Subjects; Healthy subjects will receive both interventions (active and sham) in a randomized and counterbalanced order. Each stimulation session will be at least 1 week apart to prevent carry-over effects	Procedure: Transcranial Direct Current Stimulation (tDCS); Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA. For active tDCS, the subject will undergo stimulation for 20 minutes. For sham stimulation, the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.; Other Names: low intensity 1x1 direct current stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in EEG (alpha and beta activity)	Determine whether treatment with tDCS coupled with visual illusion change cortical activity as assessed with electroencephalography (EEG). We hypothesize that tDCS plus visual illusion increase in alpha activity and inhibit beta activity and this will be associated with pain reduction in patients with moderate to severe below-level spinal cord injury (SCI) pain. EEG measurements will take place throughout the subject's participation in the study, measured at: baseline, immediately pre- and post- stimulation and at follow-up visits for a total of approximately 6 weeks.	Measured for approximately 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cortical excitability	To investigate whether active tDCS combined with visual illusion induces changes in motor cortex and as indexed by single and paired-pulse transcranial magnetic stimulation (TMS) as compared with sham tDCS coupled with visual illusion. We will also determine whether these changes are correlated with the clinical outcome (pain reduction). TMS measurements will take place throughout the subject's participation in the study, measured at: baseline, immediately pre- and post- stimulation and at follow-up visits for a total of approximately 6 weeks.	Measured for approximately 6 weeks

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (ESTIMATE): July 27, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Perceptual Disorders; Chronic Pain; Wounds and Injuries; Spinal Cord Injuries; Illusions
• Other Study ID Numbers: 2010-p-001978

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No