Computerized Cognitive Training to Protect Cognitive Function Among Hypertension Patients

NCT ID: NCT05704270

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-03-30

Brief Summary

Hypertension is an risk factor for cognitive impairment. The primary objective of this study is to evaluate the efficacy of 12-week computerized cognitive training in people with hypertension and mild cognitive impairment. The researchers will further investigate the long-term effects of cognitive training by prolonging the intervention for 24 weeks among a randomly selected sub-group.

Detailed Description

This study is a double-blinded, randomized controlled trial. A total of 200 hypertension patients with mild cognitive impairment will be recruited to participate in this study after screening. These patients will be randomized to two arms under masking. The intervention arm will receive multi-domain adaptive cognitive training using a tablet. The control arm will receive an active control treatment and use the same tablet to receive the cognitive training tasks with weak difficulty change. Both arms will receive the same intervention dosage for 12 weeks, 5 times a week, and 30 minutes per time. After the 12-week intervention, the intervention arm will be re-randomized into two groups. One group will stop their intervention at 12 weeks; the other group will continue to receive the multi-domain adaptive cognitive training till the 24-week follow-up assessment.

The neuro-psychological assessment will be administered at baseline, 12-week, and 24-week assessments for all participants. The structural and functional MRI will be administered at baseline, 12 weeks, and 24 weeks to evaluate the effect of cognitive training on brain structure and function.

Conditions

Mild Cognitive Impairment; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Adaptive cognitive training

This arm is the intervention arm. Participants randomized to this arm will use a tablet to receive the multi-domain adaptive cognitive training, which will be delivered 30 minutes at least 5 times a week for 12 weeks.

Group Type: EXPERIMENTAL

Multi-domain adaptive cognitive training

Intervention Type: BEHAVIORAL

The multi-domain adaptive cognitive training covers seven aspects of fundamental cognitive function, including sensory perception, cognitive flexibility, attention, memory, language, logic calculation, and emotion recognition and management. A self-adaptive algorithm is embedded in the tablet-based cognitive training platform, which will help deliver suitable tasks at the right difficulty level for each participant according to their personal profile and real-time performance. The intervention dosage is 30 minutes per time, 5 times a week.

Active control

This arm is the control arm. Participants randomized to this arm will use the same tablet to receive the cognitive training of low difficulty level with no adaptive change. The intervention dosage will be the same, which is 30 minutes each time, at least 5 times a week for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Basic cognitive training with no difficulty change

Intervention Type: BEHAVIORAL

The basic cognitive training for the control arm will also be delivered via a tablet. The training tasks will be fixed at a primary difficulty level without adaptive algorithm. The intervention dosage is also 30 minutes per time, 5 times a week.

Interventions

Multi-domain adaptive cognitive training

The multi-domain adaptive cognitive training covers seven aspects of fundamental cognitive function, including sensory perception, cognitive flexibility, attention, memory, language, logic calculation, and emotion recognition and management. A self-adaptive algorithm is embedded in the tablet-based cognitive training platform, which will help deliver suitable tasks at the right difficulty level for each participant according to their personal profile and real-time performance. The intervention dosage is 30 minutes per time, 5 times a week.

Intervention Type: BEHAVIORAL

Basic cognitive training with no difficulty change

The basic cognitive training for the control arm will also be delivered via a tablet. The training tasks will be fixed at a primary difficulty level without adaptive algorithm. The intervention dosage is also 30 minutes per time, 5 times a week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Older than 60 years;

2. Completed 6 or more years of education;

3. Untreated or under treatment hypertension;

4. Complaint of memory decline within 1 year;

5. Global cognitive score measured by the Montreal Cognitive Assessment is below 26;

6. Agree to receive cognitive function evaluation, randomization, and follow-up investigation as required;

Exclusion Criteria

1. Unable to complete cognitive function evaluation due to vision, hearing, and other problems;

2. Have been diagnosed of dementia or MMSE score ≤ 20;

3. Unable to use the cognitive training equipment after 2 times instructions;

4. Alcohol abuse or taking drugs that could affect cognitive function (antihistamines, antipsychotics);

5. Diabetes patients;

6. Moderate to severe decrease in glomerular filtration rate (eGFR<30 ml/min /1.73m2);

7. Systolic blood pressure ≥180 mmHg or/and diastolic blood pressure ≥110 mmHg; or orthostatic hypotension (defined as the third standing SBP<100mmHg);

8. History of cardiovascular events or hospitalization due to cardiovascular diseases in the last 3 months;

9. Planned to receive coronary intervention, atrial fibrillation ablation or cardiac surgery within 6 months; or have received these intervention strategies in the last 3 months;

10. Symptomatic heart failure or left ventricular ejection fraction <50%；

11. Atrial fibrillation confirmed by ECG with marked and severe onset of symptoms;

12. A history of stroke, or head injury in the last 6 months; past history of brain tumor or neurosurgery;

13. Past history of Parkinson's disease, Alzheimer's disease, schizophrenia, and epilepsy;

14. Have Ever undergone surgery under general anesthesia in the last three months;

15. Severe hepatic impairment or in critical condition patients with very poor prognosis whose expected survival is less than 6 months; or diagnosed of malignant tumor other than non-melanoma skin cancer in the last 2 years;

16. Contradictions for MRI examination: such as metal implantation, claustrophobia, etc.;

17. Unable to obtain an informed consent or currently taking part in other clinical trials

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Wispirit Technology Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chang sheng Ma

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang sheng Ma

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital

Beijing, , China

Ruijing Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Countries

China

Central Contacts

Yu Kong

Role: CONTACT

ky5166@126.com

086-13811901076

Facility Contacts

Yu Kong

Role: primary

Qianhui Guo

Role: primary

References

Kong Y, Guo QH, Zhou L, He L, Zeng Y, Du X, Dong JZ, Jiang C, Wang JG, Ma CS. Digital computerised cognitive training for preventing cognitive decline among hypertensive patients: a study protocol for a multicentre randomised controlled trial (DELIGHT trial). BMJ Open. 2024 Feb 29;14(2):e079305. doi: 10.1136/bmjopen-2023-079305.

Reference Type: DERIVED

PMID: 38423771 (View on PubMed)

Other Identifiers

2022BFAZ01

Identifier Type: -

Identifier Source: org_study_id