tDCS Intervention in Breast Cancer Survivors With and Without Obesity Reporting Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Helsinki
About this trial
The goal of this intervention is to investigate whether transcranial Direct Current Stimulation (tDCS) can alleviate Cancer-Related Cognitive Impairment (CRCI) in breast cancer survivors, as measured by changes in brain structures and cognitive performance. To assess the efficacy of tDCS, the investigators will compare outcomes between participants receiving active stimulation and those receiving sham stimulation (a placebo condition where participants believe they are receiving stimulation, but are not).
Participants will:
* Undergo a baseline MRI session * Receive either active or sham tDCS for six weeks * Undergo a follow-up MRI session * Complete cognitive tests and respond to psychosocial questionnaires before, during, and after the tDCS intervention
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
Over 18 years old
Diagnosed with primary adult-onset breast cancer within the last 5 years
Completed all active cancer treatments at least 3 months prior to study participation
Disqualifiers
Have received primary cancer treatment (chemotherapy, radiotherapy, immunotherapy, or surgery) within the last 3 months
Have a history of childhood-onset cancer
Present with acute eczema on the scalp
Diagnosed with dementia, Alzheimer's disease, multiple sclerosis, or - Parkinson's disease
Trial design
Design model
Parallel
Treatments tested in this trial
active tDCS
DeviceThe anodal electrode will be placed over the left DLPFC (F3), and the cathodal electrode will be placed over the right supraorbital area (FP2). The current will be gradually ramped up to 2mA over 30 seconds, held constant at 2mA for 29 minutes, and then gradually ramped down to 0mA over the final 30 seconds.
sham tDCS
DeviceThe anodal electrode will be placed over the left DLPFC (F3), and the cathodal electrode will be placed over the right supraorbital area (FP2). The current will be initially ramped up to 2mA over 30 seconds and immediately ramped back down to 0mA.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active tDCSExperimental treatment 1 intervention
Group B: sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Attention at post-intervention
Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.
Time frame
From baseline to the end of the intervention at 6 weeks2
Short-term episodic memory at post-intervention
Performance in the dot memory task under active tDCS compared to sham: the mean Euclidean distance score. The mean Euclidean distance score reflects the distance between the original red dot locations and the recalled locations.
Time frame
From baseline to the end of the intervention at 6 weeks3
Processing speed at post-intervention
Performance in Symbol Search task under active tDCS compared to sham: prompt-level median response latency for correct trials.
Time frame
From baseline to the end of the intervention at 6 weeksSecondary outcomes
1
Attention at short-term follow-up
Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.
Time frame
From baseline to 3 weeks after the end of the intervention2
Short-term episodic memory at short-term follow-up
Performance in the dot memory task under active tDCS compared to sham: the mean Euclidean distance score. The mean Euclidean distance score reflects the distance between the original red dot locations and the recalled locations.
Time frame
From baseline to 3 weeks after the end of the intervention3
Processing speed at short-term follow-up
Performance in Symbol Search task under active tDCS compared to sham: prompt-level median response latency for correct trials.
Time frame
From baseline to 3 weeks after the end of the intervention4
Attention at long-term follow-up
Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials.
Time frame
From baseline to 9 weeks after the end of the interventionOther outcomes
1
Dynamics of attention skills throughout the intervention
Performance in the Matching Cards task under active tDCS compared to sham: the mean number of correct trials from each prompted assessment.
Time frame
From baseline to week 1-3-5 during the the intervention2
Dynamics of short-term episodic memory skills throughout the intervention
Performance in the dot memory task under active tDCS compared to sham: the mean Euclidean distance score from each prompted assessment.
Time frame
From baseline to week 1-3-5 during the the intervention3
Dynamics of processing speed skills throughout the intervention
Performance in Symbol Search task under active tDCS compared to sham: the mean of the prompt-level median response latency for correct trials.
Time frame
From baseline to week 1-3-5 during the the intervention4
Depression and anxiety score at post-intervention
HADS score under active tDCS compared to sham.
Time frame
From baseline to the end of treatment at 6 weeksSponsors and contacts
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Source ClinicalTrials.gov