Transcranial Direct Current Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors
16. juli 2026 opdateret af: University of Michigan Rogel Cancer Center
Improving Sensorimotor Function in CIPN: A Randomized, Sham Controlled, Double Blinded, Crossover Mechanistic Trial of Transcranial Direct Current to the Sensorimotor Cortex
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Eshaka Eshwar
- Telefonnummer: 734-232-5901
- E-mail: eshaka@med.umich.edu
Studiesteder
-
-
Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Rogel Cancer Center
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Ledende efterforsker:
- Brendan L. McNeish
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Kontakt:
- Eshaka Eshwar
- Telefonnummer: 734-232-5901
- E-mail: eshaka@med.umich.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Arm I (active tDCS)
Patients undergo tDCS to the sensorimotor cortex, using the Starstim-8™ system, for 20 minutes.
One week later, patients cross-over to Arm II.
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Hjælpestudier
Undergo tDCS
Andre navne:
|
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Sham-komparator: Arm II (sham tDCS)
Patients undergo sham tDCS to the sensorimotor cortex, using the Starstim-8™ system, for 20 minutes.
One week later, patients cross-over to Arm I.
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Hjælpestudier
Undergo sham tDCS
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vibration detection threshold
Tidsramme: at weeks 2 and 3
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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.
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at weeks 2 and 3
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cold detection threshold
Tidsramme: 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.
|
at weeks 2 and 3
|
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Correlation between executive function and chemotherapy-induced peripheral neuropathy (CIPN) severity
Tidsramme: At baseline
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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.
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At baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Brendan L McNeish, University of Michigan Rogel Cancer Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. februar 2028
Studieafslutning (Anslået)
1. februar 2028
Datoer for studieregistrering
Først indsendt
18. juni 2026
Først indsendt, der opfyldte QC-kriterier
24. juni 2026
Først opslået (Faktiske)
29. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UMCC 2025.097
- NCI-2026-03995 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- HUM00276508 (Anden identifikator: University of Michigan Rogel Cancer Center)
Plan for individuelle deltagerdata (IPD)
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