Multi-Modal Digital Monitoring of Disease Symptoms Huntington's Disease
NCT07315984, Not yet recruiting, BioSensics
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Multi-Modal Digital Monitoring of Disease Symptoms Huntington's Disease | ClinicalTrials.gov |
| NCT number | NCT07315984 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 75 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | BioSensics | ClinicalTrials.gov |
| Conditions | Huntington Disease | ClinicalTrials.gov |
| First posted | 2026-01-05 | ClinicalTrials.gov |
| Last updated | 2026-10-13 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant | 12 months | Daily walking duration (hours) will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits. | ClinicalTrials.gov |
| Primary | Change in daily number of sit to stand transitions (count) during activities of daily living from baseline to 12 months as measured by the PAMSys pendant. | 12 months | Daily number of sit to stand transitions will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits. | ClinicalTrials.gov |
| Secondary | Change in scores of Unified Huntington's Disease Rating Scale (UHDRS) from baseline to 12 months | 12 months | A clinical tool used to assess motor, cognitive, and behavioral symptoms in individuals with Huntington's disease (HD). There are 5 parts to UHDRS 1. Total Motor Score: Scores range from 0 to 124. Higher scores represent a worse outcome. 2. Total Functional Capacity: Scores range from 0 to 13. Lower scores represent a worse outcome. 3. Behavioral Assessment: Scores range from 0 to 88. Higher scores represent a worse outcome. 4. Cognitive Assessments: Inclues Stroop test, Verbal Fluency, and Symbol Digit Modalities Test. Lower scores represent a worse outcome. | ClinicalTrials.gov |
| Secondary | Change in intelligibility when reading a standard Rainbow passage from baseline to 12 months as measured by BioDigit Speech | 12 months | Speech data will be collected from participants while reading a standard Rainbow passage on a monthly basis for 12 months. BioDigit Speech, and automatic speech analysis software, will be used to analyze the collected speech data to calculate intelligibility of speech during reading a standard Rainbow passage. | ClinicalTrials.gov |
| Secondary | Change in walking speed during activities of daily living from baseline to 12 months as measured by the PAMSys Ankle sensor | 12 months | median, 90 percentile and 96 percentile stride velocity (m/s) will be measured by the PAMSys Ankle sensor. PAMSys Ankle sensor will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits. | ClinicalTrials.gov |
| Secondary | Change in cadence during activities of daily living from baseline to 12 months as measured by the PAMSys pendant | 12 months | Median, 90 percentile and 96 percentile cadence (steps/min) will be measured by the PAMSys pendant. PAMSys pendant will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits. | ClinicalTrials.gov |
| Secondary | Change in the Montreal Cognitive assessment (MoCA) score | 12 months | The MoCA will be assessed from participants during baseline, 3 month, 6 month, 9 month and 12 month visits. | ClinicalTrials.gov |
| Other | Change in tapping rate (number of taps per minute) from baseline to 12 months as measured by the BioDigit Clinic and BioDigit Home tablets | 12 months | Finger tapping test will be collected from participants on a monthly basis for 12 months. | ClinicalTrials.gov |
| Other | Change in daily number of hand goal-directed movements during activities of daily living from baseline to 12 months as measured by the PAMSys ULM wrist sensor | 12 months | PAMSys ULM wrist sensor measures goal directed movements of the hand during activities of daily living. PAMSys ULM wrist sensors will be worn for 1 week after the baseline, 3 month, 6 month, 9 month, and 12 month visits. | ClinicalTrials.gov |
| Other | Change in the Verbal Fluency test score | 12 months | Verbal fluency test data will be collected at baseline, 3 month, 6 month, 9 month and 12 month visits. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R44TR005381 | A Wearable Sensor Platform for Remote Monitoring of Motor Impairment in Huntingtons Disease and Prodromal Huntingtons Disease | VAZIRI, ASHKAN; ADAMS, JAMIE LYNN | BIOSENSICS, LLC | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2025 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Finger Tapping Task | Other outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)