A clinical trial to study the effect of auditory training in improving cognition in individuals with mild cognitive impairment.
- Conditions
- Health Condition 1: G311- Senile degeneration of brain, notelsewhere classified
- Registration Number
- CTRI/2023/06/054277
- Lead Sponsor
- eelavathi T
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Phase I & II: Study Group
Patients with a diagnosis of Mild Cognitive Impairment as per the National Institute of Aging Alzheimers Association NIA AA
MoCA scores 19 to 25
Audiometric thresholds less than 40 dBHL in 250 500 and 1000 Hz
Participants with normal middle ear function which will be confirmed using Interacoustics middle ear analyzer
Education level greater than 8th grade
Phase I- Control Group
Age and hearing-matched controls
MoCA scores greater than 25
Educational level greater than 8th grade.
Both Groups:
Patients undergoing cognitive or behavioural interventions to improve cognition
Presence or history of other neurological disorders like stroke epilepsy brain injury or tumor based on their medical history
Presence of psychological illness based on Patient Health Questionnaire PHQ 9
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognition: <br/ ><br>i.The ACE- III- Total scores <br/ ><br>ii.Mental rotation test: Reaction time in milliseconds & response accuracy <br/ ><br>iii.Digit span test: Length of longest digits recalled- forward & backward <br/ ><br>iv.Trail Making test: Response time in seconds <br/ ><br>v.Attention Network Test: Total scores <br/ ><br>Timepoint: 4-time points- Baseline, four weeks after treatment, Post-treatment (8 weeks), One-month follow-up post-treatment.
- Secondary Outcome Measures
Name Time Method i.DDT- Right ear scores, left ear scores & total correct scores. <br/ ><br>ii.QuickSiN- SNR loss in dB <br/ ><br>iii.Gap detection threshold at all frequencies. <br/ ><br>iv.TFS-AF- Highest frequency as threshold. <br/ ><br>v.Frequency Modulation Difference Limen- Modulation rate (Hz) <br/ ><br>vi.Temporal Modulation Transfer Function- a graph of amplitude modulation as function of frequencyTimepoint: 4-time points- Baseline, four weeks after treatment, Post-treatment (8 weeks), One-month follow-up post-treatment.;Neurophysiological changes: <br/ ><br>EEG Connectivity measures (Phase Locking Value & Coherence)Timepoint: 2- time points, Baseline & post- treatment (8 weeks)