Trial Outcomes & Findings for Use of Two Deep Brain Stimulation (DBS) Electrodes to Treat Post-Traumatic Tremor (NCT NCT00954421)
NCT ID: NCT00954421
Last Updated: 2014-07-25
Results Overview
Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor. Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Change from Baseline to Six Months
Results posted on
2014-07-25
Participant Flow
Participant milestones
| Measure |
Multiple Sclerosis Tremor On VIM and VO
Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
|
|---|---|
|
Screening
STARTED
|
16
|
|
Screening
COMPLETED
|
13
|
|
Screening
NOT COMPLETED
|
3
|
|
Baseline
STARTED
|
13
|
|
Baseline
COMPLETED
|
13
|
|
Baseline
NOT COMPLETED
|
0
|
|
6 Months of DBS
STARTED
|
13
|
|
6 Months of DBS
COMPLETED
|
12
|
|
6 Months of DBS
NOT COMPLETED
|
1
|
|
VIM=ON VO=ON at 6 Months
STARTED
|
12
|
|
VIM=ON VO=ON at 6 Months
COMPLETED
|
12
|
|
VIM=ON VO=ON at 6 Months
NOT COMPLETED
|
0
|
|
VIM=OFF VO=OFF at 6 Months
STARTED
|
12
|
|
VIM=OFF VO=OFF at 6 Months
COMPLETED
|
12
|
|
VIM=OFF VO=OFF at 6 Months
NOT COMPLETED
|
0
|
|
VIM=OFF VO=ON at 6 Months
STARTED
|
12
|
|
VIM=OFF VO=ON at 6 Months
COMPLETED
|
12
|
|
VIM=OFF VO=ON at 6 Months
NOT COMPLETED
|
0
|
|
VIM=ON VO=OFF at 6 Months
STARTED
|
12
|
|
VIM=ON VO=OFF at 6 Months
COMPLETED
|
11
|
|
VIM=ON VO=OFF at 6 Months
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Multiple Sclerosis Tremor On VIM and VO
Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
|
|---|---|
|
Screening
screen failures
|
3
|
|
6 Months of DBS
Withdrawal by Subject
|
1
|
|
VIM=ON VO=OFF at 6 Months
Withdrawal by Subject
|
1
|
Baseline Characteristics
Use of Two Deep Brain Stimulation (DBS) Electrodes to Treat Post-Traumatic Tremor
Baseline characteristics by cohort
| Measure |
All Subjects
n=13 Participants
All eligible subjects were enrolled and the intent was to treat for six months on dual lead deep brain stimulation in the VIM and VO regions.
|
|---|---|
|
Age, Continuous
|
41.54 years
STANDARD_DEVIATION 15.03 • n=93 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
|
Baseline Total Fain-Tolosa-Marin Tremor Rating Scale (TRS)
|
56.2 units on a scale
STANDARD_DEVIATION 9.4 • n=93 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Six MonthsPopulation: All Subjects completing Period 4
Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor. Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline).
Outcome measures
| Measure |
Multiple Sclerosis Tremor On VIM and VO
n=12 Participants
Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
|
TRS Scale Vo Only on vs. Vim Only on at 6 Months
Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Vo only on -VM only on at 6 months.
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
|
|---|---|---|
|
Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Both VIM and VO ON (Baseline Minus 6 Months Post-implant)
|
-17.6 units on a scale
Standard Deviation 19.4
|
—
|
SECONDARY outcome
Timeframe: Baseline to Six MonthsPopulation: Patients completing 6 months were tested for VIM and VO both on vs. both off. Score is TRS scale with both off minus both on. Positive value favors DBS.
Tremor was evaluated using the Fain-Tolosa-Marin Tremor Rating Scale (TRS). Score was obtained by summing all 21 items, each of which assessed tremor on a scale of 0-4. Because some of the 21 items contained more than one subsection, total maximum score was 144, and minimum score was 0. Higher scores represent worse tremor. Both VIM and VO stimulators will be turned ON and TRS score at 6 months will be compared to pre-implant (baseline). Either VO or VIM stimulator will be turned on (as opposed to both stimulators, as in outcome measure 1), and change in Tremor Rating Scale scores will be compared. The effects of each individual stimulator will also be compared to both being turned on.
Outcome measures
| Measure |
Multiple Sclerosis Tremor On VIM and VO
n=12 Participants
Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
|
TRS Scale Vo Only on vs. Vim Only on at 6 Months
n=11 Participants
Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Vo only on -VM only on at 6 months.
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
|
|---|---|---|
|
Fain-Tolosa-Marin Tremor Rating Scale (TRS) Change Score for Either VIM or VO On, and for Both VIM and VO Off (Baseline Minus 6 Months Post-implant)
|
8.4 units on a scale
Standard Deviation 9.1
|
0.73 units on a scale
Standard Deviation 8.49
|
Adverse Events
Multiple Sclerosis Tremor On VIM and VO
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Multiple Sclerosis Tremor On VIM and VO
n=13 participants at risk
Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
|
|---|---|
|
Infections and infestations
Superficial Wound Infection
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Infections and infestations
Infection at site of IPG (pulse generator for DBS implant)
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Injury, poisoning and procedural complications
Death
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Psychiatric disorders
Change in mental status
|
15.4%
2/13 • Number of events 2 • Baseline, 6 months, 24 months
|
|
Nervous system disorders
Exacerbation of Multple Sclerosis symptoms
|
7.7%
1/13 • Number of events 3 • Baseline, 6 months, 24 months
|
|
Injury, poisoning and procedural complications
Right fractured femur
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Surgical and medical procedures
Complications with device hardware
|
15.4%
2/13 • Number of events 2 • Baseline, 6 months, 24 months
|
|
Surgical and medical procedures
Implantation of tunneled intrathecal catheter and subcutaneous implantation of a programmable pump
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
Other adverse events
| Measure |
Multiple Sclerosis Tremor On VIM and VO
n=13 participants at risk
Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation
Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis.
|
|---|---|
|
Infections and infestations
Clostridium Difficile Infection
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Infections and infestations
Fever
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Gastrointestinal disorders
Gastrointestinal discomfort
|
23.1%
3/13 • Number of events 6 • Baseline, 6 months, 24 months
|
|
General disorders
speech difficulty
|
30.8%
4/13 • Number of events 6 • Baseline, 6 months, 24 months
|
|
General disorders
swallowing difficulty
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
General disorders
lightheadedness
|
7.7%
1/13 • Number of events 2 • Baseline, 6 months, 24 months
|
|
Nervous system disorders
facial numbness
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Nervous system disorders
trigeminal neuralgia
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
weakness
|
23.1%
3/13 • Number of events 5 • Baseline, 6 months, 24 months
|
|
Musculoskeletal and connective tissue disorders
decreased mobility
|
15.4%
2/13 • Number of events 5 • Baseline, 6 months, 24 months
|
|
General disorders
worsened balance
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Injury, poisoning and procedural complications
fall
|
23.1%
3/13 • Number of events 5 • Baseline, 6 months, 24 months
|
|
Immune system disorders
worsening of nasal allergies
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Respiratory, thoracic and mediastinal disorders
laryngitis
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
General disorders
headache
|
46.2%
6/13 • Number of events 8 • Baseline, 6 months, 24 months
|
|
General disorders
pain behind left ear
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
General disorders
pain under left eye
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
General disorders
neck pain
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
General disorders
back pain
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
General disorders
lower breast pain
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
General disorders
internal capsule pulling
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
General disorders
pain on left side of head
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Psychiatric disorders
crying
|
23.1%
3/13 • Number of events 3 • Baseline, 6 months, 24 months
|
|
Psychiatric disorders
irritability
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Injury, poisoning and procedural complications
scalp tenderness
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Injury, poisoning and procedural complications
head pain at crania cap
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Injury, poisoning and procedural complications
pinching at site of pulse generator
|
15.4%
2/13 • Number of events 2 • Baseline, 6 months, 24 months
|
|
Nervous system disorders
Twiddler syndrome
|
15.4%
2/13 • Number of events 2 • Baseline, 6 months, 24 months
|
|
Injury, poisoning and procedural complications
scar tissue formation at site of DBS
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Injury, poisoning and procedural complications
irritation at site of pulse generator
|
23.1%
3/13 • Number of events 3 • Baseline, 6 months, 24 months
|
|
Infections and infestations
urinary tract infection
|
15.4%
2/13 • Number of events 3 • Baseline, 6 months, 24 months
|
|
General disorders
eczema
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Nervous system disorders
intra-operative seizure
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Psychiatric disorders
fatigue
|
30.8%
4/13 • Number of events 5 • Baseline, 6 months, 24 months
|
|
Eye disorders
eyelid fluttering
|
7.7%
1/13 • Number of events 2 • Baseline, 6 months, 24 months
|
|
Nervous system disorders
tremor in bottom lip
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Psychiatric disorders
tremor in abdomen
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
|
Psychiatric disorders
insomnia
|
15.4%
2/13 • Number of events 2 • Baseline, 6 months, 24 months
|
|
Nervous system disorders
nocturnal myoclonus of lower extremities
|
7.7%
1/13 • Number of events 1 • Baseline, 6 months, 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place