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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-03995 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00276508 | Other Identifier | University of Michigan Rogel Cancer Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (active tDCS) | Experimental | Patients undergo tDCS to the sensorimotor cortex, using the Starstim-8â„¢ system, for 20 minutes. One week later, patients cross-over to Arm II. |
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| Arm II (sham tDCS) | Sham Comparator | Patients undergo sham tDCS to the sensorimotor cortex, using the Starstim-8â„¢ system, for 20 minutes. One week later, patients cross-over to Arm I. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Intervention | Procedure | Undergo sham tDCS |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | at weeks 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoe Sowers | Contact | 734-936-1208 | zsowers@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brendan L McNeish | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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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.
| Survey Administration | Other | Ancillary studies |
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| Transcranial Direct Current Stimulation | Device | Undergo tDCS |
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| at weeks 2 and 3 |
| 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. | At baseline |
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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