About this trial
This clinical trial tests how well a type of non-invasive brain stimulation called transcranial direct current stimulation (tDCS) works to treat chemotherapy induced peripheral neuropathy (CIPN) in cancer survivors. CIPN is numbness, tingling, pain, and movement problems that can develop after chemotherapy as a result of changes to the nerves. A non-invasive form of brain stimulation called tDCS, applied to the area of the brain involved in sensation and movement, can temporarily improve the ability to detect vibration and temperature, as well as balance and walking, which may improve sensation and reduce pain in cancer survivors with CIPN.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 85 years of age
Diagnosis of cancer, stages I-IV
Cancer survivor (not currently receiving chemotherapy, radiation, or immunotherapy)
Presence of CIPN defined as new, length-dependent numbness, tingling, and/or pain that developed with neurotoxic chemotherapy
Disqualifiers
Known brain metastases
Known neurological conditions aside from chemotherapy-induced peripheral neuropathy (CIPN)
History of brain or spinal surgery
Neuropathy other than CIPN
Trial design
Crossover
Treatments tested in this trial
Sham Intervention
Procedure/SurgeryUndergo sham tDCS
Survey Administration
Other interventionAncillary studies
Transcranial Direct Current Stimulation
DeviceUndergo tDCS
Treatment groups
Trial outcomes
Primary outcomes
Vibration detection threshold
Assessed via Vibration Detection Threshold (CASE IV): Quantitative sensory testing (QTS) for large fiber function. Will conduct a series of two-way analysis of variance (ANOVAs) with each of the vibratory thresholds, cold thresholds, and physical function measures as the dependent variables. Group (active transcranial direct current stimulation \[tDCS\] versus sham tDCS) and time (baseline, immediate post) will be included as fixed factors of interest along with their interaction to assess treatment effects over time.
Secondary outcomes
Cold detection threshold
Assessed via Cold Detection Threshold (CASE IV): QST for small fiber function. Will conduct a series of two-way ANOVAs with each of the vibratory thresholds, cold thresholds, and physical function measures as the dependent variables. Group (active tDCS versus sham tDCS) and time (baseline, immediate post) will be included as fixed factors of interest along with their interaction to assess treatment effects over time.
Correlation between executive function and chemotherapy-induced peripheral neuropathy (CIPN) severity
Assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN20. Will use multivariable models with CIPN20 as the dependent variable, executive function as the primary predictor, and sural amplitude as a covariate. Additional covariates will include age, sex, depression, and pain.
Sponsors and contacts
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