Trials / Not Yet Recruiting
Not Yet RecruitingNCT07159100
tDCS for Cancer-Related Fatigue and Weakness
Neuromodulation as a Therapeutic Intervention to Improve Cancer Related Fatigue and Weakness
- Status
- Not Yet Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Kessler Foundation · Academic / Other
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-09-10
- Primary completion
- 2027-08-31
- Completion
- 2027-12-31
- First posted
- 2025-09-08
- Last updated
- 2025-09-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07159100. Inclusion in this directory is not an endorsement.