C LINICAL S TAFF T RAINING P RESENTATION 1 Crystal Blais, Ph.D. Scientific Affairs Liaison Training...

CLINICAL STAFF TRAINING PRESENTATION

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Crystal Blais, Ph.D.Scientific Affairs LiaisonTraining Program Manager

© 2014 Nuraleve, Inc. Proprietary and Confidential.13-11-2014

SOP-LI-03-57 Rev C

Defining Chronic Pain

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Definitions: Pain

Pain

An unpleasant sensory or emotional experience associated with potential or actual tissue damage, or described in terms of such damage

33© 2014 Nuraleve, Inc. Proprietary and Confidential.

Definitions: Nervous System


Definitions: Nociception

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How injury leads to pain

Steps: Transduction: from noxious stimuli at nociceptors to nerve

impulses

Transmission: nerve impulses from periphery to CNS

Perception: the experience of pain

Modulation: modulation of pain from brain to spinal cord

Sensitization – important for chronic pain development

Peripheral sensitization: nociceptors generate nerve impulses easier

Central sensitization: spinal neuron hyper-excitability


Classes of pain

Acute pain

Chronic pain (or chronic non-cancer pain)

Cancer pain

Acute pain Occurs in response to tissue trauma

Goes away when injury heals

Serves an important biological function


Chronic Pain: Definition

Chronic pain features: Pain that persists past the normal time of healing

Pain lasting longer than 12 weeks*

Low levels of underlying pathology that do not explain the presence and/or extent of the pain

Perpetuated by factors remote from the cause

Pain continues to occur (continuous or intermittently) without acute exacerbations

A persistent pain that “disrupts sleep and normal living, ceases to

serve a protective function, and instead degrades health and

functional capability”


Causes of Chronic Pain

Acute injury (e.g., whiplash)

Chronic conditions (e.g., multiple sclerosis)

In some cases: no discernable cause


tDCS: How It Works

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Background

Transcranial direct current stimulation (tDCS)

Non-invasive technique

Administered using scalp electrodes

Low amounts of current (DC)

standard dose: 2 mA

Stimulates select regions of the brain

For chronic pain: motor cortex (M1)

Session duration: 20 minutes


Background


Two electrodes:

Anode Cathode

Current flows from anode to cathode

Two methods of stimulation:

Anodal stimulation

Cathodal stimulation

Cortical Excitability


Anodal stimulation

Increased cortical excitability

Cathodal stimulation

Decreased cortical excitability

tDCS changes how our neural circuits respond to stimuli

tDCS & Neuromodulation


Long-term brain changes via tDCS occur due to:

1. Modulation of neurotransmitter activity glutamate GABA

2. Neuronal excitation Long-term potentiation (LTP) Increased synaptic strength/efficacy

3. Neuroplasticity Functional changes

tDCS & Chronic Pain


Anodal stimulation of the motor cortex (MI1)results in decreased pain due to:

Decreased processing of pain signals Via suppression of sensory neurons in thalamus

Decreased activity in somatosensory cortex Via direct pathway with M1

Endogenous opioid release

Safe Use

tDCS is safe when applied within standard safety guidelines

Minor adverse events include: Mild tingling sensation Drowsiness Itching/burning Headache Light headedness

No major side effects or serious adverse events have been reported


Contraindications

Patients may not be eligible for Painrelief if they:

Are under 18 years of age

Have had a recent (<6 months ago) head injury

Have a history of seizures/epilepsy

Have metal embedded in the skull

Have a pacemaker and/or other implanted electrical devices

Have lesions, lipomas, open wounds or bruising on the scalp at the electrode site


tDCS & Chronic Pain: Studies

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tDCS & Chronic Pain: Indications

Fibromyalgia

Migraines

Diabetic neuropathy

Chronic back pain

Trigeminal neuralgia

Polyneuropathy

Atypical face pain

Arthrosis

Post-stroke pain

Phantom pain


tDCS & the Motor Cortex (M1)


Decreased pain intensity Decreased pain frequency Decreased pain duration Improved quality of life Improved sleep quality

Beneficial effects are both acute and long-lasting Effects seen up to 4 months post-treatment

Anodal stimulation of M1 results in:

Anodal tDCS of M1: Studies


Study Population SampleSize Sessions Efficacy % Responders

Gonçalves et al., 2014

Chronic lower back and/or lower limb

pain20 5 →80% responders (i.e., reduction of 50% or more

in pain intensity) in the active group 80%

Kim et al., 2013

Painful diabetic polyneuropathy

(PDPN)60 5

After 5th session:→20-50% reduction (from baseline) in pain scores →65% of participants reported ≥30% decrease)→Illness severity decreased (from baseline) 31.5%

→Pain reduced up to 4 weeks post-treatment

65%

Wrigley et al., 2013

Neuropathic pain due to

spinal cord injury 10 5 None 10%



Study Population SampleSize Sessions Efficacy %

Responders

DaSilva et al., 2012 Chronic migraine 13 10

From baseline to 4 months post-stimulation:→migraine intensity: from 4.6 to 2.9→length of migraine (hrs): from 8 to .9

From baseline to 30 days post-stimulation:→75% of patients saw moderate improvement with partial remission of symptoms

75%

Mendonca et al., 2011 Fibromyalgia 30 1 None N/A

Antal et al., 2010

Therapy-resistant chronic pain

syndrome12 5

After 5 sessions: →63% responders (i.e., reduction of 30% or more in pain intensity)

Decrease in pain intensity (change from baseline): →After 5th session: 33.5%→7 days post-study: 11%→14 days post-study: 28%→28 days post-study: 27%

63%



Study Population SampleSize Sessions Efficacy %

Responders

Valle et al., 2009

Fibromyalgia (women only) 41 10

Pain scores: values not given

Quality of life: →28% improvement

Not reported

Roizenblatt et al., 2007 Fibromyalgia 32 5

Pain scores:→59% decrease

Sleep measures:→decreased arousal: 35%→increased sleep efficacy: 12%

Not reported

Fregni et al., 2006a

Central pain after traumatic spinal

injury17 5

Pain scores:→After 5 sessions: 58% decrease→During follow-up (16 days post-treatment): 37%

5 sessions: 63%Follow-up: 36%

Fregni et al., 2006b Fibromyalgia 32 5

Quality of life scores:→"Pain" item: 49% improvement→Overall quality of life: 36% improvement

Not reported

tDCS & Chronic Pain: Considerations

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Treatment Outcomes

Factors that affect treatment outcomes:

Age

Circadian rhythms

Resting brain states

Hormone levels

Underlying mechanisms of pain

Central sensitization


The Motor Cortex (M1)

The homunculus:


tDCS & Painrelief™

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Painrelief™ Program


Chronic pain reduction program:

10 consecutive sessions

20 minutes each

2 mA

Painrelief™ System


Painrelief™ Accessories

Accessories you will use: Skin markers

Measuring tape

Alcohol swabs

Electrodes & lead wires

Sponges

Saline solution

Electrode prep container

Batteries and chargers



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Determining electrode placement

International 10-20 System



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Cathode (right forehead)

Anode (left motor cortex)

Cathode (left forehead)

Anode (right motor cortex)

Pain on right side of body Anode: left M1 Cathode: right

forehead

Pain on left side of body Anode: right M1 Cathode: left

forehead

Pain on both sides of body

Anode: dominant hemisphere

1. Measure head midline from the nasion to the inion,

marking 10% (Fpz)



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10% Depression between eyes

Bump at back of head



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1. Measure head midline from the nasion to the inion, marking

10% (Fpz)

2. Align the cap so that the marked point is in the center of

the Fpz point.



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1. Measure head midline from the nasion to the inion,

marking 10% (Fpz)

2. Align the cap so that the marked point is in the center

of the Fpz point.

3. Mark the points C3/Fp1 (right

side pain) and C4/Fp2 (left

side pain) on the cap

Fp2Fp1

C4C3

Tips and Tricks

Hair: Split the hair around the target location. Pre-wet hair if necessary by rubbing the sponge in

the target location. Then, re-apply saline on sponge Use alcohol swab to remove marker dots from scalp

at end of session

Electrodes: Red electrode: middle should be at exact

location, with uniform pressure. Black electrode: the more contact area, the

merrier.


Tips and Tricks

WHAT YOU DON’T WANT:

Shifting of electrodes (especially red)

Shifting of electrode during initial installation at any point during the session

will result in stimulation of an incorrect brain region

Prevention:

Adjust electrode under cap as needed


Tips and Tricks

WHAT YOU DON’T WANT:

Dripping electrodes

If liquid leaks around the contact area, it may: Short the contact between electrodes (ineffective session) Change the area of contact between electrodes (modifies

effectiveness)

Too much or too little liquid affects the current density

Prevention:

Squeeze out excess saline before patient application3939© 2014 Nuraleve, Inc. Proprietary and Confidential.

Questions?


1.888.792.7922 Ext. 103

[email protected]

C LINICAL S TAFF T RAINING P RESENTATION 1 Crystal Blais, Ph.D. Scientific Affairs Liaison Training...

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