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NOT YET RECRUITING
NCT07159100
EARLY_PHASE1

tDCS for Cancer-Related Fatigue and Weakness

Sponsor: Kessler Foundation

View on ClinicalTrials.gov

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.

Official title: Neuromodulation as a Therapeutic Intervention to Improve Cancer Related Fatigue and Weakness

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2025-09-10

Completion Date

2027-12-31

Last Updated

2025-09-08

Healthy Volunteers

Yes

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.

Locations (1)

Kessler Foundation

West Orange, New Jersey, United States