Trial Outcomes & Findings for Investigating Motor Cortex Processing for Pain Modulation (NCT NCT01404039)

Results Overview

We aim to assess the effects of the intervention (ML, SL, OT and MI) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after the given intervention. * For ML: MEP will be measured before and after each ML sessions in the same subject (crossover design - ML sighted/MLblind/ML control). * For SL: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group). * For OT: MEP will be measured before and after the treatment session in the each groups (parallel - 1 session per group). * For MI: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group).

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

115 participants

Primary outcome timeframe

after each intervention

Results posted on

2020-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	Motor Learning - MLsighted/MLblind/MLcontrol This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.	Motor Learning (ML) MLblind/MLcontrol/MLsighted This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.	Motor Learning (ML) MLcontrol Group/MLsighted/MLblind This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.	Somatosensory Learning (SL Sighted) In this arm, subject will perform sensory Learning with visual feedback - SL sighted. There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).	Somatosensory Learning (SL Blind) In this arm, subject will perform sensory Learning without visual feedback - SL blind. There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).	Somatosensory Activation (S Activation) In this arm, subject will receive simple sensory stimulation over their left index finger - Sactivation. There will be an anticipated total of 10 subjects in this experimental arm.This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).	Somatosensory Learning (SL) Control Group In this arm,the subjects will not receive any somatosensory input (SL control group). There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).	Observational Task (OT) Observational Task: Subjects in this group will watch a 10 second video of a right-handed person performing movements of their left index finger at a 1 Hz rate on a screen at a distance of 1 meter away. Subjects will be instructed to watch the video without any other specific instruction.	Observational Task (OT) - Control Group Control Group -- Observational Task: Subjects in this group will be asked to watch a video of random geometric forms for the same duration of time as those in the observational task group.	Mental Imagery (MI) Mental Imagery: Subjects will be seated in a chair and are asked to keep their arm and hand muscles fully relaxed. Then they will be asked to imagine repetitive movement of the left index finger to the left thumb for 5 minutes. Subjects then will be asked to imagine sequential movement of left finger to left thumb (thumb to 2nd, 3rd, 4th, 5th) for 5 minutes.	Mental Imagery (MI) - Control Group Control Group - Mental Imagery: Subjects will be asked to perform simple mental math calculations for 20 minutes. (ex. adding or subtracting a one digit number from a starting number (1+1=2; 2+1=3; 3+1= 4 and so on.)
Overall Study STARTED	5	5	5	10	10	10	10	15	15	15	15
Overall Study COMPLETED	4	5	5	10	10	10	10	15	15	14	14
Overall Study NOT COMPLETED	1	0	0	0	0	0	0	0	0	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigating Motor Cortex Processing for Pain Modulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motor Learning (ML) n=15 Participants This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.	Somatosensory Learning (SL Sighted) n=10 Participants	Somatosensory Learning (SL Blind) n=10 Participants	Somatosensory Activation (S Activation) n=10 Participants	Somatosensory Learning (SL) Control Group n=10 Participants	Observational Task (OT) - Real n=15 Participants	Observational Task (OT) - Control n=15 Participants	Mental Imagery (MI) - Real n=15 Participants	Mental Imagery (MI) - Control n=15 Participants	Total n=115 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	15 Participants n=8 Participants	15 Participants n=8 Participants	15 Participants n=24 Participants	15 Participants n=42 Participants	115 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	15 Participants n=8 Participants	15 Participants n=8 Participants	15 Participants n=24 Participants	15 Participants n=42 Participants	115 Participants n=42 Participants

PRIMARY outcome

Timeframe: after each intervention

Population: ML: crossover design - ML sighted/MLblind/ML control. 15 patients were enrolled, but one participant dropped-out after the first intervention - participants with available data: 14. SL: parallel design - SL sighted/SLblind/Sactivation/SLcontrol. OT: parallel design - OT real and OT control. MI: parallel design - MI real and MI control.

We aim to assess the effects of the intervention (ML, SL, OT and MI) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after the given intervention. * For ML: MEP will be measured before and after each ML sessions in the same subject (crossover design - ML sighted/MLblind/ML control). * For SL: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group). * For OT: MEP will be measured before and after the treatment session in the each groups (parallel - 1 session per group). * For MI: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group).

Outcome measures

Outcome measures
Measure	Motor Learning (ML)-Sighted n=14 Participants	Motor Learning -ML Blind n=14 Participants	Motor Learning - ML Control n=14 Participants	Somatosensory Learning (SL)- SL Sighted n=10 Participants	Somatosensory Learning (SL)-SL Blind n=10 Participants	Somatosensory Learning (SL)-SL Activation n=10 Participants	Somatosensory Learning (SL)-SL Control n=10 Participants	Observational Task (OT)- OT Real n=15 Participants	Observational Task (OT)- OT Control n=15 Participants	Mental Imagery (MI) - MI Real n=14 Participants	Mental Imagery (MI) - MI Control n=15 Participants
Change in Motor Cortex Excitability MEP Amplitude After	1.27 microV Standard Deviation 0.35	1.4 microV Standard Deviation 0.28	1.49 microV Standard Deviation 0.35	1.59 microV Standard Deviation 0.73	1.47 microV Standard Deviation 0.5	1.18 microV Standard Deviation 0.39	1.28 microV Standard Deviation 0.44	1.83 microV Standard Deviation 0.74	1.65 microV Standard Deviation 0.75	1.41 microV Standard Deviation 0.81	1.66 microV Standard Deviation 1.01
Change in Motor Cortex Excitability MEP Amplitude Before	1.37 microV Standard Deviation 0.32	1.39 microV Standard Deviation 0.25	1.28 microV Standard Deviation 0.23	1.74 microV Standard Deviation 0.78	1.67 microV Standard Deviation 0.50	1.32 microV Standard Deviation 0.29	1.30 microV Standard Deviation 0.39	1.93 microV Standard Deviation 0.75	1.79 microV Standard Deviation 0.78	1.49 microV Standard Deviation 0.81	1.70 microV Standard Deviation 1.12

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Felipe Fregni

Spaulding Rehabilitation Hospital

Phone: 6179526156

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place