Transcranial Direct Current Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Michigan Rogel Cancer Center

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Sham Intervention

    Procedure/Surgery

    Undergo sham tDCS

  • Survey Administration

    Other intervention

    Ancillary studies

  • Transcranial Direct Current Stimulation

    Device

    Undergo tDCS

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Arm I (active tDCS)Experimental treatment 2 interventions
Group B: Arm II (sham tDCS)Sham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
at weeks 2 and 3

Secondary outcomes

1

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.

Time frame
at weeks 2 and 3
2

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.

Time frame
At baseline

Other outcomes

Sponsors and contacts

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