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JOURNAL ONKOLOGIE – STUDIE
NeuroMod-PCCI

Cognitive Training and Brain Stimulation in Women With Post-chemotherapy Cognitive Impairment

Noch nicht rekrutierend

NCT-Nummer:
NCT04817566

Studienbeginn:
Juni 2021

Letztes Update:
26.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Cognitive Dysfunction

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University Medicine Greifswald

Collaborator:
University of Greifswald

Studienleiter

Agnes Flöel, Prof.
Study Director
University Medicine Greifswald

Kontakt

Studienlocations
(1 von 1)

University Medicine Greifswald
Greifswald
(Mecklenburg-Vorpommern)
Germany» Google-Maps

Studien-Informationen

Detailed Description:

Patients who have undergone chemotherapy, may develop post-chemotherapy cognitive impairment

(PCCI), which may occur in several cognitive domains and persist for many years. These

declines in cognitive functions can lead to psychological distress and affect overall

patients' quality of life. The goal of the present study is to assess behavioral effects of a

multi-session cognitive training combined with high-definition transcranial direct current

stimulation (tDCS) in women with PCCI. First studies have shown positive effects of cognitive

training on trained and untrained functions and the subjective perception of stress, however

the effects are small and transfer effects are inconsistent. A promising approach to elongate

and increase the effects of cognitive training is to combine the training with tDCS.

Therefore, in this study women with PCCI will participate in a three-week cognitive training

with concurrent online high-definition tDCS application. Cognitive performance (primary), as

well as Quality of Life scores and Sleep data will be examined before, during and after the

intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive

training, a control group, receiving sham stimulation during training, will be assessed. A

Follow-up session to assess long-term effects is planned four weeks after the post

assessment. The results of the study will offer valuable insights into efficacy of combined

tDCS and cognitive training intervention in women with PCCI in order to establish its

potential to induce improvements in cognitive functions, and to beneficially affect

patient-reported outcome measures.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Chemotherapy to treat breast cancer (≥ 6 months post-treatment).

2. Self-reported concerns regarding cognitive functioning.

3. Age: 18-60 years.

Exclusion Criteria:

1. History of dementia before treatment of cancer.

2. Other neurodegenerative neurological disorders; epilepsy or history of seizures.

3. Severe and untreated medical conditions that preclude participation in the training,

as determined by responsible physician.

4. History of moderate to severe substance use disorder according to DSM-5

5. Moderate to severe acute psychiatric disorders according to DSM-5

6. Contraindication to tDCS application (Antal et al., 2017)

Studien-Rationale

Primary outcome:

1. Working memory performance at post-assessment (Time Frame - 3 weeks):
Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task



Secondary outcome:

1. Working memory performance at follow-up assessment (Time Frame - 4 weeks after training):
Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task

2. Working memory training performance (Letter Updating Task) at post-assessment (Time Frame - 3 weeks):
Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task

3. Working memory training performance (Letter Updating Task) at follow-up assessment (Time Frame - 4 weeks after training):
Performance in primary memory training task (Letter Updating Task) at follow-up assessment, operationalized by number of correctly recalled lists in the letter updating task

4. Quality of Life at post-assessment (Time Frame - 3 weeks):
PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)

5. Quality of Life at follow-up assessment (Time Frame - 4 weeks after training):
PROMIS score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function)

6. Visuo-spatial performance at post-assessment (Time Frame - 3 weeks):
Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.

7. Visuo-spatial performance at follow-up assessment (Time Frame - 3 weeks):
Visuo-spatial performance at follow-up assessment operationalized by number of correctly recalled items in the VR task.

Studien-Arme

  • Experimental: stimulation group
    Anodal tDCS+ intensive cognitive Training
  • Sham Comparator: sham group
    Sham tDCS + intensive cognitive Training

Geprüfte Regime

  • Anodal tDCS:
    Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA).
  • Sham tDCS:
    Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants.
  • Intensive cognitive training:
    Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min

Quelle: ClinicalTrials.gov


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