Recruiting

Ex+tACS

Sponsor:

Florida Atlantic University

Code:

NCT07587957

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise + transcranial alternating current stimulation (Ex+tACS)

Control

Study Details

Brief summary:

The purpose of this study is to assess the feasibility of a 4-week intervention combining exercise and transcranial alternating current stimulation (Ex+tACS) in breast cancer survivors who report experiencing cancer-related cognitive impairment. Feasibility will be assessed by measuring participant retention, adherence, satisfaction with the intervention, and safety. The researchers will also examine pre-to-post intervention changes in attention, executive function, working memory, perceived cognitive function, and physical function before, after, and four weeks post intervention completion in the Ex+tACS group compared to a control group who will receive exercise and a placebo tACS condition (CON).

Conditions

Breast Cancer

Study ID

NCT07587957

Start date

Jan 7, 2026

Status verified date

May, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Breast cancer survivors (≥18 years) will be eligible to participate if the following inclusion criteria is met:
  • Diagnosed non-metastatic breast cancer (stages 0-3)
  • Completed primary breast cancer treatment (surgery, chemotherapy, radiation) for at least 3 months
  • Self-reported cognitive impairment after cancer treatment

Exclusion Criteria:

  • Current participation in aerobic exercise for ≥60 min/wk
  • Contraindication or impairment that precludes the potential participant from exercise as defined by the American College of Sports Medicine
  • The presence of serious medical illnesses, metal implants, previous brain trauma, epilepsy or history of seizures, previous surgery to the head or spinal cord, or skin problems at the forehead area where the tACS electrodes will be applied
  • Uncontrolled cardiovascular disease
  • Functional impairments or physical condition that would make exercise unsafe
  • Metastatic cancer or diagnosis of a different cancer (excluding melanoma) within the past 5 years
  • Contraindication to exercise a defined by the American College of Sports Medicine

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

The Exercise + transcranial alternating current stimulation (Ex+tACS) group will complete a four-week intervention consisting of 3 days/week of 30 minutes of aerobic exercise on a treadmill at a sustained moderate intensity, immediately followed by 15 min of tACS. During tACS, 6Hz alternating current stimulation will be administered to participants' prefrontal cortex (forehead region) using a tACS while the participant completes the AX Continuous Performance Test (AX-CPT).

sham comparator: Control

The Sham Comparator group will complete 30 minutes of aerobic exercise on the treadmill followed by the Sustained Attention-Continuous Performance Task (AX-CPT) with a sham transcranial alternating current stimulation (tACS) condition. The same procedures will be followed regarding the tACS, but stimulation will only last one minute, ramping up and down at the beginning and end of the 15-minute period, simulating the periodic tingling sensation that are reported with tACS.

Interventions

Exercise + transcranial alternating current stimulation (Ex+tACS)

The Ex+tACS group will complete a four-week intervention consisting of 3 days/week of 30 minutes of aerobic exercise on a treadmill at a sustained moderate intensity, immediately followed by 15 min of tACS while completing the AX Continuous Performance Test (AX-CPT).

Control

The Control (CON) group will complete 30 minutes of aerobic exercise on the treadmill followed by the Sustained Attention-Continuous Performance Task (AX-CPT) with a sham tACS condition. After each session, both the EX+tACS and control participants will complete a questionnaire regarding experience with tACS.

Primary outcome measure

  • Adherence [ Time Frame: From baseline to the end of the 4-week intervention ]
  • Retention [ Time Frame: From baseline to the end of the 4-week intervention ]
  • Acceptability [ Time Frame: From baseline to the end of the 4-week intervention ]
  • Safety (Adverse Events) [ Time Frame: From baseline to the end of the 4-week intervention ]

Central Contacts and Locations

Central contacts

Ashley L Artese, PhD

856-534-8926aartese@fau.edu

Locations

Florida Atlantic University

Recruiting

Boca Raton, Florida, United States, 33431

Contacts

Ashley L Artese, PhD

856-534-8926aartese@fau.edu

More Information

Sponsor

Florida Atlantic University

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Breast Cancer
  • Cancer-related cognitive impairment
  • Non-invasive brain stimulation
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida Atlantic University on 2026-05-14.