Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia (NCT NCT01884064)

Results Overview

Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

Baseline and Day 5

Results posted on

2016-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	rTMS Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days. rTMS: rTMS	Sham rTMS Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days. rTMS: rTMS
Overall Study STARTED	12	5
Overall Study COMPLETED	12	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rTMS n=12 Participants Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days. rTMS: rTMS	Sham rTMS n=5 Participants Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days. Sham rTMS: Sham rTMS	Total n=17 Participants Total of all reporting groups
Age, Continuous	46.5 years STANDARD_DEVIATION 12.4 • n=5 Participants	46.6 years STANDARD_DEVIATION 14.8 • n=7 Participants	46.5 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 5

Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.

Outcome measures

Outcome measures
Measure	rTMS n=12 Participants Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days. rTMS: rTMS	Sham rTMS n=5 Participants Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days. rTMS: rTMS
Cortical Silent Period	9 milliseconds Standard Deviation 6.9	1.61 milliseconds Standard Deviation 15.7

Adverse Events

rTMS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Sham rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	rTMS n=12 participants at risk Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days. rTMS: rTMS	Sham rTMS n=5 participants at risk Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days. rTMS: rTMS
Psychiatric disorders Mild Headache	16.7% 2/12 • Number of events 2 • Before and after each session of the intervention Subjects were asked to report any adverse event	0.00% 0/5 • Before and after each session of the intervention Subjects were asked to report any adverse event
Psychiatric disorders Fatigue	8.3% 1/12 • Number of events 1 • Before and after each session of the intervention Subjects were asked to report any adverse event	0.00% 0/5 • Before and after each session of the intervention Subjects were asked to report any adverse event

Additional Information

Dr. Teresa Jacobson Kimberley

University of Minnesota

Phone: 612-626-4096

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place