Trial Outcomes & Findings for Optimizing tDCS to Improve Dual Task Gait and Balance (NCT NCT04295798)

NCT ID: NCT04295798

Last Updated: 2025-01-30

Results Overview

Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed pre and post tDCS. Two at a preferred speed while walking quietly (single task), two at a preferred speed while performing a cognitive task (dual task) and two fast walking trials. The cognitive task during the dual task condition was verbalized serial subtractions of 3's from a random three-digit number. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. The outcome was calculated by averaging the dual task costs of the four trials. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes
• Results posted on: 2025-01-30

Participant Flow

Participant milestones

Measure	Crossover tDCS On each visit, participants were randomly assigned to receive one of four different 20-minute tDCS interventions: Conventional tDCS, Optimized tDCS, Conventional Sham, and Optimized Sham.
Overall Study STARTED	29
Overall Study Conventional tDCS	29
Overall Study Optimized tDCS	29
Overall Study Conventional Sham	29
Overall Study Optimized Sham	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Crossover tDCS On each visit, participants were randomly assigned to receive one of four different 20-minute tDCS interventions: Conventional tDCS, Optimized tDCS, Conventional Sham, and Optimized Sham.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Optimizing tDCS to Improve Dual Task Gait and Balance

Baseline characteristics by cohort

Measure	Four Interventions in a Cross-over Design n=29 Participants Each subject participated in four sessions of interventions in different days. Conventional tDCS: One 20-minute session of active transcranial direct current stimulation (tDCS) using large sponge electrodes targeting the left dorsolateral prefrontal cortex. Optimized tDCS: One 20-minute session of active transcranial direct current stimulation (tDCS) using eight gel electrodes with placement and current parameters optimized to the cohort targeting the left dorsolateral prefrontal cortex. Conventional Sham: One 20-minute session of inactive sham in which tDCS will be delivered via sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session. Optimized Sham: One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target (left dlPFC) with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Age, Continuous	75.8 years STANDARD_DEVIATION 5.84 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index (BMI)	27.64 kg/m^2 STANDARD_DEVIATION 4.70 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed pre and post tDCS. Two at a preferred speed while walking quietly (single task), two at a preferred speed while performing a cognitive task (dual task) and two fast walking trials. The cognitive task during the dual task condition was verbalized serial subtractions of 3's from a random three-digit number. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. The outcome was calculated by averaging the dual task costs of the four trials. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Dual Task Cost to Gait Speed From Baseline to Immediately Post Intervention	-2.29 unitless Standard Deviation 4.35	-3.88 unitless Standard Deviation 2.77	0.06 unitless Standard Deviation 4.71	-0.10 unitless Standard Deviation 3.21

PRIMARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Postural sway speed was assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 45-second trials of standing with eyes open (single task), eyes closed, or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). The cognitive task was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. The outcome was obtained by averaging the dual task costs of the four trials. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Dual Task Cost to Standing Postural Sway Speed From Baseline to Immediately Post Intervention	-7.66 unitless Standard Deviation 10.38	-5.97 unitless Standard Deviation 11.03	26.88 unitless Standard Deviation 9.83	5.06 unitless Standard Deviation 11.03

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Stride time variability is a measure of how consistent limb movements are during walking and is expressed as the coefficient of variation. Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed. Two at a preferred speed while walking quietly (single task), two at a preferred speed while performing a cognitive task (dual task) and two fast walking trials. The cognitive task during the dual task condition was verbalized serial subtractions of 3's. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Dual Task Cost to Stride Time Variability From Baseline to Immediately Post Intervention	-9.86 unitless Standard Deviation 53.03	-24.96 unitless Standard Deviation 27.96	4.29 unitless Standard Deviation 34.43	0.84 unitless Standard Deviation 33.18

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed pre and post tDCS. Two at a preferred speed while walking quietly (single task). The absolute change from baseline to immediately post intervention was calculated by averaging the single task gait speeds (m/s) pre and post.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Single Task Gait Speed From Baseline to Immediately Post Intervention	0.025 m/s Standard Deviation 0.01	0.031 m/s Standard Deviation 0.012	0.017 m/s Standard Deviation 0.011	0.014 m/s Standard Deviation 0.012

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed pre and post tDCS. Two at a preferred speed while performing a cognitive task (dual task). The cognitive task during the dual task condition was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change from baseline to immediately post intervention was calculated by averaging the dual task gait speeds (m/s) pre and post.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Dual Task Gait Speed From Baseline to Immediately Post Intervention	0.046 m/s Standard Deviation 0.086	0.042 m/s Standard Deviation 0.048	-0.002 m/s Standard Deviation 0.011	0.016 m/s Standard Deviation 0.029

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Stride time variability (STV) is a measure of how consistent limb movements are during walking. It's expressed as the coefficient of variation (CoV) and calculated from the mean and standard deviation of stride time. Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed. Two at a preferred speed while walking quietly (single task). The absolute change from baseline to immediately post intervention was calculated by averaging the single task stride time variability pre and post.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Single Task Stride Time Variability From Baseline to Immediately Post Intervention	-0.07 coefficient of variation Standard Deviation 0.09	-0.04 coefficient of variation Standard Deviation 0.09	-0.06 coefficient of variation Standard Deviation 0.08	-0.03 coefficient of variation Standard Deviation 0.09

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Stride time variability (STV) is a measure of how consistent limb movements are during walking. It's expressed as the coefficient of variation (CoV) and calculated from the mean and standard deviation of stride time. Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed. Two at a preferred speed while performing a cognitive task (dual task). The cognitive task during the dual task condition was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change from baseline to immediately post intervention was calculated by averaging the dual task stride time variability pre and post.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Dual Task Stride Time Variability From Baseline to Immediately Post Intervention	-0.27 coefficient of variation Standard Deviation 1.04	-0.23 coefficient of variation Standard Deviation 0.37	-0.16 coefficient of variation Standard Deviation 0.89	-0.13 coefficient of variation Standard Deviation 0.50

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Postural sway area was assessed by measuring postural sway elliptical area during six, 45-second trials of standing with eyes open (single task), eyes closed, or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). The cognitive task was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. The outcome was obtained by averaging the dual task costs of the four trials. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Dual Task Cost to Standing Postural Sway Area From Baseline to Immediately Post Intervention	-23.17 unitless Standard Deviation 82.98	-3.18 unitless Standard Deviation 59.23	21.45 unitless Standard Deviation 71.17	-3.23 unitless Standard Deviation 58.45

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Postural sway speed was assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during two, 45-second trials of standing with eyes open (single task) on a stationary force platform (Kistler, Amherst, NY) pre and post intervention. The absolute change from baseline to immediately post intervention was calculated by averaging the single task postural sway speed (m/s) pre and post.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Single Task Postural Sway Speed From Baseline to Immediately Post Intervention	0.013 m/s Standard Deviation 0.023	-0.018 m/s Standard Deviation 0.023	-0.028 m/s Standard Deviation 0.023	0.0078 m/s Standard Deviation 0.024

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Postural sway speed was assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during two, 45-second trials of standing with eyes open while performing a cognitive task (dual task) on a stationary force platform (Kistler, Amherst, NY) pre and post intervention. The cognitive task was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change from baseline to immediately post intervention was calculated by averaging the dual task postural sway speed (m/s) pre and post.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Dual Task Postural Sway Speed From Baseline to Immediately Post Intervention	-0.0056 m/s Standard Deviation 0.016	-0.0029 m/s Standard Deviation 0.018	0.063 m/s Standard Deviation 0.017	-0.0001 m/s Standard Deviation 0.018

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Postural sway area was assessed by measuring postural sway elliptical area during two, 45-second trials of standing with eyes open (single task) on a stationary force platform (Kistler, Amherst, NY) pre and post intervention. The absolute change from baseline to immediately post intervention was calculated by averaging the single task postural sway area pre and post.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Single Task Postural Sway Area From Baseline to Immediately Post Intervention	0.0049 m² Standard Deviation 0.023	-0.001 m² Standard Deviation 0.021	0.0025 m² Standard Deviation 0.012	0.01 m² Standard Deviation 0.023

SECONDARY outcome

Timeframe: Change from baseline to immediately post-tDCS, up to 60 minutes

Postural sway area was assessed by measuring postural sway elliptical area during two, 45-second trials of standing with eyes open while performing a cognitive task (dual task) on a stationary force platform (Kistler, Amherst, NY) pre and post intervention. The cognitive task was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change from baseline to immediately post intervention was calculated by averaging the dual task postural sway area pre and post.

Outcome measures

Measure	Conventional tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 Participants One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Conventional Sham n=29 Participants One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 Participants One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Absolute Change in Dual Task Postural Sway Area From Baseline to Immediately Post Intervention	-0.0081 m² Standard Deviation 0.041	-0.0091 m² Standard Deviation 0.034	0.0025 m² Standard Deviation 0.029	0.0086 m² Standard Deviation 0.021

Adverse Events

Conventional tDCS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Optimized tDCS

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Conventional Sham

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Optimized Sham

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Conventional tDCS n=29 participants at risk One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC.	Optimized tDCS n=29 participants at risk One 20-minute session of active tDCS using eight gel electrodes with placement and current parameters optimized to the cohort targeting the left dlPFC.	Conventional Sham n=29 participants at risk One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session.	Optimized Sham n=28 participants at risk One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations.
Vascular disorders Dizziness	0.00% 0/29 • 8 weeks	3.4% 1/29 • Number of events 1 • 8 weeks	3.4% 1/29 • Number of events 1 • 8 weeks	0.00% 0/28 • 8 weeks
Injury, poisoning and procedural complications Fall	0.00% 0/29 • 8 weeks	0.00% 0/29 • 8 weeks	3.4% 1/29 • Number of events 1 • 8 weeks	0.00% 0/28 • 8 weeks
Investigations Blood iron decreased	3.4% 1/29 • Number of events 1 • 8 weeks	0.00% 0/29 • 8 weeks	0.00% 0/29 • 8 weeks	0.00% 0/28 • 8 weeks
Injury, poisoning and procedural complications Muscle strain	0.00% 0/29 • 8 weeks	0.00% 0/29 • 8 weeks	3.4% 1/29 • Number of events 1 • 8 weeks	3.6% 1/28 • Number of events 1 • 8 weeks
Nervous system disorders Headache	0.00% 0/29 • 8 weeks	0.00% 0/29 • 8 weeks	3.4% 1/29 • Number of events 1 • 8 weeks	3.6% 1/28 • Number of events 1 • 8 weeks
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/29 • 8 weeks	0.00% 0/29 • 8 weeks	0.00% 0/29 • 8 weeks	3.6% 1/28 • Number of events 1 • 8 weeks
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/29 • 8 weeks	0.00% 0/29 • 8 weeks	0.00% 0/29 • 8 weeks	3.6% 1/28 • Number of events 1 • 8 weeks

Additional Information

Junhong Zhou

Hebrew SeniorLife

Phone: 617-971-5346

Email: JunhongZhou@hsl.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place