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Table 3 tDCS Anticipated Risks and Risk Mitigation

From: Remotely monitored transcranial direct current stimulation in pediatric cerebral palsy: open label trial protocol

Anticipated Risks

Risk Mitigation

Burn- Electrolysis

Ensure proper electrode contact with skin

Stimulation in subjects with reduced sensation

Assess sensation, avoid placing electrodes over areas of decreased sensation

Stimulation over broken skin, reduced resistance

Assess skin integrity, avoid placement of electrodes over recent shaving, skin defects

Stimulation over conductive implants

Screen appropriately for exclusion criteria of implants

Stimulation over a tumor which may alter metabolic activity

Screen appropriately for exclusion criteria of neoplasm

Threshold altering pharmacologic agent

Screen appropriately for exclusion criteria of centrally acting agent

Itching, Tingling, Burning Sensation in the area of the electrodes

Ensure proper contact of surface electrodes with skin. Maintain current dosage within low-range of researched dosages. Ensure that electrode sponges are properly sanitized and that saline solution is appropriately employed.

Headache

Ensure that headband securing electrodes is in proper placement, yet not to the level of impingement of scalp area. Maintain current dosage within low range of delivery.

Pain- Neck, Scalp

Ensure that electrodes are in proper contact with skin and adjust head position as needed for comfort

Skin Redness

Ensure proper electrode position and proper level of moisture to even stimulation across the electrode

Fatigue, Sleepiness

Screen for continuous effect at follow-up visit

Concentration or Mood Changes

Evaluate cognitive status through physician examination