Means to improve cognition in healthy elderly and patients with mild cognitive impairment – from training to non-invasive brain stimulatio

Phase 2

• Conditions: MCI (Mild Cognitive Impairment)

• Registration Number: DRKS00025122
• Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-10
• Study Completion: 2023-10-28
• Results First Posted: 2024-02-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Mild cognitive impairment (MCI) or cognitive ability in the context of healthy aging.
2. The ability to voluntarily give consent to participate in the study.

Exclusion Criteria

1. Pacemakers, deep brain stimulation
2. Intracerebral metal implants (e.g. clips after surgery of an intracerebral aneurysms, implantation of an artificial cochlea)
3. Evidence of epileptic seizures or stroke in the medical history.
4. Age < 55 or > 85 years.
5. Craniocerebral trauma with loss of consciousness in the previous history
6. Presence of a serious internal or neurological disease (e.g. untreated tumors, cancer)
7. Serious neurological or psychiatric diseases (except MCI) (schizophrenia, Parkinson's disease, multiple sclerosis, severe depression)
8. Glaucoma, retinitis pigmentosa
9. blood pressure > 160/100 Hgmm
10. OPs within the last three months
11. Chemotherapy within the last 12 months
12. Alcohol, medicine and drug addiction
13. Receptive or global aphasia (disturbance of speech understanding or additionally of speaking)
14. Drugs at the time of inclusion (Neuroleptics, Benzodiazepines, Antiepileptic drugs)
15. Participation in another clinical trial within the last 8 weeks

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is an improved cognitive performance measured by the Paired associate learning (PAL) test. The PAL test is administered immediately before the start of the stimulation series (baseline level), immediately after the stimulation series (immediate effects), and 3 months after the completion of the stimulation series (long-term effects).

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is an improved cognitive performance measured by the Montreal cognitive assessment (MoCA), the Rey Auditory Verbal Learning Test (RAVL), the Corsi block-tapping task (CORSI), the Trail Making Test (TMT), the Craft Story 21, the Attention network test (ANT), the Alternating Serial Reaction Time (ASRT) task and the Sustained Attention to Response task (SART). Tests will be administered immediately before the start of the stimulation series (baseline level), immediately after the stimulation series (immediate effects), and 3 months after the completion of the stimulation series (long-term effects). Another secondary endpoint is improved performance on the N-Back Task, which is used for cognitive training during brain stimulation, i.e., 16 appointments.