Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
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.
Interventions
PROCEDURESham Intervention
Undergo sham tDCS
OTHERSurvey Administration
Ancillary studies
DEVICETranscranial Direct Current Stimulation
Undergo tDCS
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants will receive an active sham protocol in which low-level currents are circulated across electrodes for the full 20-minute session. This mimics the sensation of active stimulation without significantly affecting cortical excitability. This method will effectively blind participants and study personnel to group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 * CIPN20 score ≥ 20 * Able to walk unassisted * Proficient in English
Exclusion criteria
* Known brain metastases * Known neurological conditions aside from chemotherapy-induced peripheral neuropathy (CIPN) * History of brain or spinal surgery * Neuropathy other than CIPN * Significant hearing or vision deficits * Vestibulopathy * Currently receiving chemotherapy, radiation therapy, or immunotherapy * Contraindications to transcranial direct current stimulation (tDCS), including recent seizures * Presence of metallic objects in the head * Presence of specific implanted medical devices (e.g., deep brain stimulator, cochlear implant, vagus nerve stimulator, spinal cord stimulator, pacemakers, and intracardiac devices) * Active scalp dermatological conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vibration detection threshold | at weeks 2 and 3 | 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
| Measure | Time frame | Description |
|---|---|---|
| Cold detection threshold | at weeks 2 and 3 | 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 | At baseline | 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. |
Countries
United States
Contacts
CONTACTEshaka Eshwar
PRINCIPAL_INVESTIGATORBrendan L McNeish
University of Michigan Rogel Cancer Center
Outcome results
None listed