Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05984056
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2023-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase
Sponsor:
Vineet Punia MD
Organization:
Study Overview
Official Title:
Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase (MINDS)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINDS
Brief Summary:
This clinical trial aims to test the impact of multidisciplinary lifestyle interventions (MLI) in neurologically healthy but at-risk individuals. It aims to find out:
* if giving four different kinds of lifestyle intervention and education slows down or reverses the expression of neurological disorder or their biomarkers.
* new biomarkers that either help in the early detection of neurological disease or identify the impact of various lifestyle interventions combined.
Participants will be randomized to the intervention or observation arm. Various biological samples and tests, along with survey questionnaires, will be performed at the time of entering the study, at 12 weeks after enrollment, and then at the end of the study at 12 months.
* Intervention arm: Participants will receive weekly, instructor-led intervention sessions (virtual group sessions) for 12 weeks. After the 12-week mark, participants will be encouraged to practice what they learned for nine more months.
* Observation arm: The intervention group will be compared to another group that did not get the intervention
* if giving four different kinds of lifestyle intervention and education slows down or reverses the expression of neurological disorder or their biomarkers.
* new biomarkers that either help in the early detection of neurological disease or identify the impact of various lifestyle interventions combined.
Participants will be randomized to the intervention or observation arm. Various biological samples and tests, along with survey questionnaires, will be performed at the time of entering the study, at 12 weeks after enrollment, and then at the end of the study at 12 months.
* Intervention arm: Participants will receive weekly, instructor-led intervention sessions (virtual group sessions) for 12 weeks. After the 12-week mark, participants will be encouraged to practice what they learned for nine more months.
* Observation arm: The intervention group will be compared to another group that did not get the intervention
Detailed Description:
In this prospective, controlled, randomized study, investigators will enroll neurologically healthy but at-risk individuals (defined based on the pre-defined, disease-specific criteria described below in the "Eligibility" section) to assess the effectiveness of multidisciplinary lifestyle interventions \[MLI, which includes the following: brain health training, yoga, music therapy, and Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase (MINDS) diet education\] on delaying, preventing, or reversing the progressive expression of known and novel neurological disorder biomarkers.
The study team will accomplish the abovementioned objectives by comparing 200 participants randomly assigned to the MLI arm (12 weekly instructor-led virtual group sessions followed by nine months of self-practice) or the control arm. All participants (including those enrolled in the control arm) will receive the MIND Study Activity Survey every two weeks during this first 12-week period.
Participants will undergo neuroimaging, neuropsychology, and neurophysiology testing and provide biosamples for genomic, proteomic, and metabolomic analysis along with various survey questionnaires at 3-time points: study enrollment, at the 12-week mark, and at the end of the study (12-month).
The primary outcome of the study is "pathology progression," which will be considered positive when the known biomarker used for initial participant selection increases over the study period. Rest will be considered as not showing "pathology progression." Various biomarkers collected using the abovementioned tests will be compared within and between the intervention and observation groups, and their correlation to pathology progression will be analyzed. This longitudinal, correlational testing will help this exploratory study reveal potential novel biomarkers of early neurological disorder and the ones that show the impact of MLI.
The study team will accomplish the abovementioned objectives by comparing 200 participants randomly assigned to the MLI arm (12 weekly instructor-led virtual group sessions followed by nine months of self-practice) or the control arm. All participants (including those enrolled in the control arm) will receive the MIND Study Activity Survey every two weeks during this first 12-week period.
Participants will undergo neuroimaging, neuropsychology, and neurophysiology testing and provide biosamples for genomic, proteomic, and metabolomic analysis along with various survey questionnaires at 3-time points: study enrollment, at the 12-week mark, and at the end of the study (12-month).
The primary outcome of the study is "pathology progression," which will be considered positive when the known biomarker used for initial participant selection increases over the study period. Rest will be considered as not showing "pathology progression." Various biomarkers collected using the abovementioned tests will be compared within and between the intervention and observation groups, and their correlation to pathology progression will be analyzed. This longitudinal, correlational testing will help this exploratory study reveal potential novel biomarkers of early neurological disorder and the ones that show the impact of MLI.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: