Effect of Music-based Brain Stimulation and Exercise Games to Improve Brain Function in People with Type 2 Diabetes Mellitus

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Binaural Beats + Exer‐gaming: Participants will receive both exergaming and binaural beats interventions for 6 weeks. Exergaming will be administered for 30 minutes per session, three times per week, using interactive balance‐based cognitive‐motor games with progressive difficulty and dual‐task components in later weeks. Binaural beats will be delivered for 15 minutes per session, three times per week via stereo headphones, using theta frequencies in the initial phase followed by beta frequencies. Both interventions will be provided either on the same day with rest intervals or on alternate days. Control Intervention1: Binaural Beats: Participants will receive auditory brainwave entrainment using binaural beats delivered through stereo headphones in a quiet environment for 15 minutes per session, three times per week for 6 weeks. The protocol will involve theta frequency stimulation during the initial phase, progressing to beta frequency stimulation in later weeks to enhance cognitive function. Control Intervention2: Exer‐gaming: Participants will undergo exergaming training for 30 minutes per session, three times per week for 6 weeks using a sensor‐based interactive balance platform. The intervention will include progressive levels of difficulty, focusing on postural control, coordination, and cognitive engagement, with introduction of dual‐task training in later stages. Control Intervention3: Control: Participants will continue their usual daily activities without receiving any structured intervention for 6 weeks. They will be instructed not to initiate any new exercise, cognitive, or relaxation programs during the study period to avoid confounding effects. CONDITION: Health Condition 1: E119‐ Type 2 diabetes mellitus without complications PRIMARY OUTCOME: Prefrontal ActivityTimepoint: At Baseline ; At 6 weeks SECONDARY OUTCOME: Attention‐ Digit Span Forward and Digit Span Backward, Stroop Colour and Word Test Visuospatial Ability‐ Clock Drawing Test Executive function‐ Trail Making Test Memory‐ Rey Auditory Verbal Learning TestTimepoint: At Baseline ; At 6 weeks INCLUSION CRITERIA: Adults aged 40 65 years with a diagnosis of Type 2 Diabetes Mellitus for at least 5 years, having stable glycemic control (HbA1c between 6.5% and 10%), mild cognitive impairment (MoCA score 19 26), and medically fit to participate in moderate physical activity will be included. Participants must have adequate hearing ability, be able to undergo EEG and P300 assessments, and be willing to provide informed consent and comply with the study protocol.
Epistemonikos ID: be07623dfe2a088b7e8eeb7834501ddb32408a69
First added on: Aug 08, 2026