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

NCT01404065 | Terminated

• 1 other identifier: 2010-p-001978
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Spinal Cord Injury

Keywords

transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in cortical excitability

  Measured for approximately 6 weeks

Study Arms (3)

Active tDCS + visual illusion

EXPERIMENTAL

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)

Sham tDCS + visual illusion

SHAM COMPARATOR

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)

Healthy Subjects

OTHER

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)

Interventions

Transcranial Direct Current Stimulation (tDCS) PROCEDURE

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.

Also known as: low intensity 1x1 direct current stimulator

Active tDCS + visual illusion; Healthy Subjects; Sham tDCS + visual illusion

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Providing informed consent to participate in the study
• 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 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)
• Pain is not attributable to other causes, such as peripheral inflammation

You may not qualify if:

• Clinically significant or unstable medical or psychiatric disorder
• History of substance abuse
• 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
• Implanted devices for pain control, such as vagal or deep brain stimulators
• Contraindications to tDCS:
• metal in the head
• implanted brain medical devices
• Pregnancy
• Use of ventilators or ventilation support
• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chronic Pain; Spinal Cord Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Felipe Fregni, MD, PhD, MPH

  Spaulding Rehabilitation Hospital (SRH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 27, 2011
• Study Start: December 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)