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tDCS for Cancer-Related Fatigue and Weakness

NCT07159100 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-08

No results posted yet for this study

Summary

This pilot study investigates the effectiveness of non-invasive brain stimulation (tDCS) in alleviating cancer-related fatigue (CRF) and muscle weakness. Using a randomized, double-blind crossover design, participants perform fatiguing muscle tasks with and without tDCS, and outcomes include task endurance, maximal voluntary contraction force, and neuromuscular markers. Neural mechanisms will be assessed via EEG, TMS, and MRI.

Conditions

  • Cancer-related Fatigue
  • Neuromodulation

Interventions

DEVICE

Active tDCS + elbow flexion exercise

Participants will receive anodal tDCS targeting motor-related cortical areas using either traditional sponge-based or high-definition (HD)-tDCS configurations. The intervention is delivered at 1.5-2.0 mA for 20-30 minutes, either before or during a sustained submaximal isometric contraction task designed to induce fatigue. tDCS will be administered in a counterbalanced crossover design, where each participant completes both active stimulation and sham stimulation conditions in separate sessions spaced at least one week apart. Sham stimulation mimics the sensory effects of active tDCS (30-second ramp-up and down) without delivering sustained current. The intervention is unique as the target population is cancer survivors with persistent fatigue \>6 months post-treatment. Also, the tDCS is combined with neurophysiological assessments, including EMG, TMS, EEG, and MRI, to provide neurophysiological evidence of acute effects.

DRUG

Sham tDCS + elbow flexion exercise

Participants will receive anodal tDCS targeting motor-related cortical areas using either traditional sponge-based or high-definition (HD)-tDCS configurations. The intervention is delivered at 1.5-2.0 mA for 30 seconds to mimic the sensation of active tDCS (20 minutes long), either before or during a sustained submaximal isometric contraction task designed to induce fatigue. tDCS will be administered in a counterbalanced crossover design, where each participant completes both active stimulation and sham stimulation conditions in separate sessions spaced at least one week apart. Sham stimulation mimics the sensory effects of active tDCS (30-second ramp-up and down) without delivering sustained current.

Sponsors & Collaborators

  • Kessler Foundation

    lead OTHER

Principal Investigators

  • Guang Yue, PhD · Kessler Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07159100 on ClinicalTrials.gov